Clinical Study of Resistant Starch in Improving Constipation
NCT ID: NCT06292949
Last Updated: 2024-03-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-27
Study Completion Date
2024-09-25
Brief Summary
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Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation.
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Detailed Description
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Human intestinal microbiota is one of the densest microbial communities on earth, including highly diverse microbial communities, which provide metabolic, immune and protective functions and play a vital role in human health. Gastrointestinal microflora is affected by many factors, including genetics, host physiology (host age, disease, stress, etc.) and environmental factors, such as living conditions and drug use. At the same time, diet is considered to be a key environmental factor mediating gastrointestinal microflora composition and metabolic function . In view of the fact that it is difficult to be digested and absorbed by the human body, probiotics can enter the intestinal tract through the digestive tract, so as to improve intestinal microecology and promote lipid, protein and mineral metabolism.
Food rich in anti-digestible starch has many functions, such as controlling body weight, reducing blood lipids and blood sugar, regulating intestinal flora and so on, which has attracted the interest of many scholars and become a new field of international food research in recent years. Resistant starch (RS) is the anti-digestion part of compound polysaccharide starch. According to the conditions of enzymatic hydrolysis resistance and starch source, the digestible resistant starch was mainly divided into four types, namely RS1, RS2, RS3 and RS4. From the cause of resistance, RS1 and RS2 have natural resistance to amylase, and the resistance can disappear after gelatinization, while the resistance of RS3 and RS4 is formed by the transformation of starch in the process of food processing or food production. RS1 can coexist with RS2 or RS3 in the same kind of food, and the existence of RS4 can increase the food intake of RS3.
Only a small part of the digestible starch can be digested and absorbed in the small intestine, providing a very low utilization rate of glucose. When most of the rest of the undigested components enter the colon, they are fermented by the intestinal microflora, mainly producing short-chain fatty acids (SCFAs): acetate, propionate and butyrate. Although both acetate and propionate have health effects, butyrate is particularly thought to improve health and is the SCFA with the largest increase in RS intake. Butyrate plays an important role in human intestinal health, including reducing inflammation, reducing the risk of colon cancer and improving intestinal barrier function. In vivo and in vitro, resistant starch diet and butyrate significantly increased the proportion of ChAT immunoreactive intermuscular neurons, intestinal neurons expressed monocarboxylic acid transporter 2 (MCT2), small interference with RNA silenced MCT2, and prevented butyrate-induced increase in the proportion of ChAT immunoreactive neurons. Butyrate and trichostatin An increased the acetylation of histone H3 in intestinal neurons. Src signal pathway inhibitors can block the effect of butyrate. Resistant starch diet increased colonic transport, and butyrate increased cholinergic-mediated contraction of colonic circular muscles in vitro. Although RS has been shown to be one of the best fibers to increase butyrate levels in the population, it is clear that not everyone can get the same benefits, and some people do not respond to RS supplementation. This suggests that differences in individual microflora play an important role in determining the outcome of RS consumption, and we need to explore more deeply the mechanism of RS digestion and how it leads to the production of butyrate. In addition, more needs to be done to understand the health effects that may be affected by RS consumption beyond butyrate levels.
Due to the complex structure of RS, certain bacteria are required to initiate the degradation of this semi-crystalline material. R. bromii and Bifidobacterium juvenis are the only known human intestinal microorganisms with RS degrading ability.
R. bromii has received attention for its role as a keystone species for RS metabolism, feeding, and/or enabling other members of the gut microbiome to access this substrate. The starch-breaking enzyme of R. bromii has a unique organizational structure and forms a multi-enzyme complex, which is attached to the cell surface through the scaffold protein in the fibrinosomes through the adhesion protein and dockerin modules, so it is called amylasome. This system has been found in a variety of human rumenococcus, and the key enzyme structure of its amylasome is highly conserved across strains. Despite its incredible ability to degrade RS, R. bromii itself does not seem to outcompete or dominate other species, but rather serves a beneficial purpose by cross-feeding other species by releasing different lengths of sugars and acetate. One study found that median fecal butyrate increased by 50% after treatment with potato starch (RS2), but further examination of individual responses revealed different changes in butyrate. A follow-up study by the same group found that those with increased R. bromii abundance in their microbiota were more likely to have a higher butyrate response to potato starch, suggesting that the right combination of primary degrading bacteria and resistant starch is needed to increase butyrate production.
Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation \[16\]. Clinically, refractory constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. From the research data analysis point of view, as a natural, safe, "medicine and food" food resources, like dietary fiber, has a very important role in human health. It has important industrial application value and broad market development prospect, opens up a new field of functional food research, and makes up for the disadvantages of traditional dietary fiber.
In our previous analysis, stool microorganisms of 20 constipation patients and 20 healthy people were found to be very different in structure. The difference analysis indicated that Ruminococcus was abundant in healthy people. A classification model of AUROC0.967 was established using Lasso algorithm, and important features of the classification model were as follows: Ruminococcus is the feature with the highest weight. SPINGO notes that the genus Ruminococcus contains species, in which R. bromii has the highest relative abundance. A search of data from the GMrepo database revealed that Ruminococcus were found in 28,796 trials, belonging to 93 phenotypes. A total of 40,795 valid runs belonged to these phenotypes. The relative abundance of Ruminococcus in healthy people is significantly higher than that in constipated people, and the relative abundance of R. bromii in healthy people is significantly higher than that in constipated people. The relative abundance of Ruminococcus in healthy people was significantly higher than that in constipated people. Therefore, the purpose of this clinical trial is to supplement resistant starch for constipation patients and (1) observe whether the symptoms of constipation patients are improved; (2) To analyze the changes of intestinal microbes in patients with constipation; (3) Verify whether the relative abundance of R. bromii increases and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation.
The study was a non-randomized controlled study with no placebo group and enrolled 30 patients with functional constipation diagnosed by doctors. A questionnaire survey is used to understand whether the symptoms of constipation patients are improved. At the same time, stool samples are collected for metagenome sequencing analysis to study the changes of intestinal microbes of patients before and after the resistant starch intervention. Special attention is paid to whether the relative abundance of R. bromii is increased.
This study does not require recruitment advertisements, and subjects are recruited on a completely voluntary basis. Possible risks during the experiment are explained to subjects and informed consent is signed after they agree to join the study. The volunteers who agreed to join the experiment were surveyed by questionnaire to obtain their intestinal health and other health conditions, and screened according to the above research object selection criteria and exclusion criteria. The samples collected are named by the number, and the personal information of the subject will not be disclosed.The identity of the subjects was kept secret throughout the study, and only the number and disease phenotype were visible. Subjects may withdraw from the study at any time.
In this study, the composition and structure of the intestinal flora of the subjects will be analyzed, and the subjects can keep abreast of the progress of the test and analysis and obtain their own relevant data.
The resistant starch used in this study (HiMaize260) is produced by Ingredion. HI-MAIZE®260 resistant starch is a dietary fiber derived from Ingredion's proprietary high-amylose corn starch that enhances the nutritional content of everyday foods such as white bread, muffins, cookies, cakes and pasta.
The HI-MAIZE®260 standard is GB31637-2016, which conforms to the national standards for food safety. The HI-MAIZE®260 resistant starch contains approximately 53% resistant starch (dietary fiber) and 40% digestible starch and can be easily added to standard formulations by partially replacing plain flour. In addition, because HI-MAIZE®260 resistant starch contains fewer calories than flour, it enhances the nutritional content of food.
Food rich in anti-digestible starch has many functions, such as controlling body weight, reducing blood lipids and blood sugar, regulating intestinal flora and so on, which has attracted the interest of many scholars and become a new field of international food research in recent years. Resistant starch (RS) is the anti-digestion part of compound polysaccharide starch. According to the conditions of enzymatic hydrolysis resistance and starch source, the digestible resistant starch was mainly divided into four types, namely RS1, RS2, RS3 and RS4. From the cause of resistance, RS1 and RS2 have natural resistance to amylase, and the resistance can disappear after gelatinization, while the resistance of RS3 and RS4 is formed by the transformation of starch in the process of food processing or food production. RS1 can coexist with RS2 or RS3 in the same kind of food, and the existence of RS4 can increase the food intake of RS3.
Only a small part of the digestible starch can be digested and absorbed in the small intestine, providing a very low utilization rate of glucose. When most of the rest of the undigested components enter the colon, they are fermented by the intestinal microflora, mainly producing short-chain fatty acids (SCFAs): acetate, propionate and butyrate. Although both acetate and propionate have health effects, butyrate is particularly thought to improve health and is the SCFA with the largest increase in RS intake. Butyrate plays an important role in human intestinal health, including reducing inflammation, reducing the risk of colon cancer and improving intestinal barrier function. In vivo and in vitro, resistant starch diet and butyrate significantly increased the proportion of ChAT immunoreactive intermuscular neurons, intestinal neurons expressed monocarboxylic acid transporter 2 (MCT2), small interference with RNA silenced MCT2, and prevented butyrate-induced increase in the proportion of ChAT immunoreactive neurons. Butyrate and trichostatin An increased the acetylation of histone H3 in intestinal neurons. Src signal pathway inhibitors can block the effect of butyrate. Resistant starch diet increased colonic transport, and butyrate increased cholinergic-mediated contraction of colonic circular muscles in vitro. Although RS has been shown to be one of the best fibers to increase butyrate levels in the population, it is clear that not everyone can get the same benefits, and some people do not respond to RS supplementation. This suggests that differences in individual microflora play an important role in determining the outcome of RS consumption, and we need to explore more deeply the mechanism of RS digestion and how it leads to the production of butyrate. In addition, more needs to be done to understand the health effects that may be affected by RS consumption beyond butyrate levels.
Due to the complex structure of RS, certain bacteria are required to initiate the degradation of this semi-crystalline material. R. bromii and Bifidobacterium juvenis are the only known human intestinal microorganisms with RS degrading ability.
R. bromii has received attention for its role as a keystone species for RS metabolism, feeding, and/or enabling other members of the gut microbiome to access this substrate. The starch-breaking enzyme of R. bromii has a unique organizational structure and forms a multi-enzyme complex, which is attached to the cell surface through the scaffold protein in the fibrinosomes through the adhesion protein and dockerin modules, so it is called amylasome. This system has been found in a variety of human rumenococcus, and the key enzyme structure of its amylasome is highly conserved across strains. Despite its incredible ability to degrade RS, R. bromii itself does not seem to outcompete or dominate other species, but rather serves a beneficial purpose by cross-feeding other species by releasing different lengths of sugars and acetate. One study found that median fecal butyrate increased by 50% after treatment with potato starch (RS2), but further examination of individual responses revealed different changes in butyrate. A follow-up study by the same group found that those with increased R. bromii abundance in their microbiota were more likely to have a higher butyrate response to potato starch, suggesting that the right combination of primary degrading bacteria and resistant starch is needed to increase butyrate production.
Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation \[16\]. Clinically, refractory constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. From the research data analysis point of view, as a natural, safe, "medicine and food" food resources, like dietary fiber, has a very important role in human health. It has important industrial application value and broad market development prospect, opens up a new field of functional food research, and makes up for the disadvantages of traditional dietary fiber.
In our previous analysis, stool microorganisms of 20 constipation patients and 20 healthy people were found to be very different in structure. The difference analysis indicated that Ruminococcus was abundant in healthy people. A classification model of AUROC0.967 was established using Lasso algorithm, and important features of the classification model were as follows: Ruminococcus is the feature with the highest weight. SPINGO notes that the genus Ruminococcus contains species, in which R. bromii has the highest relative abundance. A search of data from the GMrepo database revealed that Ruminococcus were found in 28,796 trials, belonging to 93 phenotypes. A total of 40,795 valid runs belonged to these phenotypes. The relative abundance of Ruminococcus in healthy people is significantly higher than that in constipated people, and the relative abundance of R. bromii in healthy people is significantly higher than that in constipated people. The relative abundance of Ruminococcus in healthy people was significantly higher than that in constipated people. Therefore, the purpose of this clinical trial is to supplement resistant starch for constipation patients and (1) observe whether the symptoms of constipation patients are improved; (2) To analyze the changes of intestinal microbes in patients with constipation; (3) Verify whether the relative abundance of R. bromii increases and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation.
The study was a non-randomized controlled study with no placebo group and enrolled 30 patients with functional constipation diagnosed by doctors. A questionnaire survey is used to understand whether the symptoms of constipation patients are improved. At the same time, stool samples are collected for metagenome sequencing analysis to study the changes of intestinal microbes of patients before and after the resistant starch intervention. Special attention is paid to whether the relative abundance of R. bromii is increased.
This study does not require recruitment advertisements, and subjects are recruited on a completely voluntary basis. Possible risks during the experiment are explained to subjects and informed consent is signed after they agree to join the study. The volunteers who agreed to join the experiment were surveyed by questionnaire to obtain their intestinal health and other health conditions, and screened according to the above research object selection criteria and exclusion criteria. The samples collected are named by the number, and the personal information of the subject will not be disclosed.The identity of the subjects was kept secret throughout the study, and only the number and disease phenotype were visible. Subjects may withdraw from the study at any time.
In this study, the composition and structure of the intestinal flora of the subjects will be analyzed, and the subjects can keep abreast of the progress of the test and analysis and obtain their own relevant data.
The resistant starch used in this study (HiMaize260) is produced by Ingredion. HI-MAIZE®260 resistant starch is a dietary fiber derived from Ingredion's proprietary high-amylose corn starch that enhances the nutritional content of everyday foods such as white bread, muffins, cookies, cakes and pasta.
The HI-MAIZE®260 standard is GB31637-2016, which conforms to the national standards for food safety. The HI-MAIZE®260 resistant starch contains approximately 53% resistant starch (dietary fiber) and 40% digestible starch and can be easily added to standard formulations by partially replacing plain flour. In addition, because HI-MAIZE®260 resistant starch contains fewer calories than flour, it enhances the nutritional content of food.
Conditions
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Constipation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Resistant starch intervention group
or the recruited patients with functional constipation, stool samples were collected and 2 packets of resistant starch were taken every day, each packet of 10g. The resistant starch was brewed with 200ml warm water for 14 days, and the fecal samples of volunteers were collected on the 0th, 7th and 14th day. Patients filled out questionnaires on days 0 and 14 to evaluate the improvement of constipation symptoms.
Group Type
EXPERIMENTAL
Resistant starch
Intervention Type
DIETARY_SUPPLEMENT
Constipated patients take 1 pack of resistant starch (20g/pack) daily for 14 days
Interventions
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Resistant starch
Constipated patients take 1 pack of resistant starch (20g/pack) daily for 14 days
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* The clinical manifestation is constipation, which meets the diagnostic criteria of Roman IV constipation.
Exclusion Criteria
* Colonoscopy excludes patients with colorectal tumors within one or two years
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Huaping Xie
OTHER
Sponsor Role
lead
Responsible Party
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Huaping Xie
Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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ping h Xie
Role: STUDY_CHAIR
Tongji Medical College of Huazhong University of Science and Technology
Locations
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Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology
Wuhan, Hubei, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Ni Y, Qian L, Siliceo SL, Long X, Nychas E, Liu Y, Ismaiah MJ, Leung H, Zhang L, Gao Q, Wu Q, Zhang Y, Jia X, Liu S, Yuan R, Zhou L, Wang X, Li Q, Zhao Y, El-Nezami H, Xu A, Xu G, Li H, Panagiotou G, Jia W. Resistant starch decreases intrahepatic triglycerides in patients with NAFLD via gut microbiome alterations. Cell Metab. 2023 Sep 5;35(9):1530-1547.e8. doi: 10.1016/j.cmet.2023.08.002.
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RESULT
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RESULT
Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
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RESULT
Goldsmith JR, Sartor RB. The role of diet on intestinal microbiota metabolism: downstream impacts on host immune function and health, and therapeutic implications. J Gastroenterol. 2014 May;49(5):785-98. doi: 10.1007/s00535-014-0953-z. Epub 2014 Mar 21.
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RESULT
Holscher HD. Dietary fiber and prebiotics and the gastrointestinal microbiota. Gut Microbes. 2017 Mar 4;8(2):172-184. doi: 10.1080/19490976.2017.1290756. Epub 2017 Feb 6.
Reference Type
RESULT
Bach Knudsen KE, Laerke HN, Hedemann MS, Nielsen TS, Ingerslev AK, Gundelund Nielsen DS, Theil PK, Purup S, Hald S, Schioldan AG, Marco ML, Gregersen S, Hermansen K. Impact of Diet-Modulated Butyrate Production on Intestinal Barrier Function and Inflammation. Nutrients. 2018 Oct 13;10(10):1499. doi: 10.3390/nu10101499.
Reference Type
RESULT
Zheng L, Kelly CJ, Battista KD, Schaefer R, Lanis JM, Alexeev EE, Wang RX, Onyiah JC, Kominsky DJ, Colgan SP. Microbial-Derived Butyrate Promotes Epithelial Barrier Function through IL-10 Receptor-Dependent Repression of Claudin-2. J Immunol. 2017 Oct 15;199(8):2976-2984. doi: 10.4049/jimmunol.1700105. Epub 2017 Sep 11.
Reference Type
RESULT
Sindo T, Haga K, Yamamoto Y, Hayashi Y, Ozawa K. Studies on the interference between the allergic reactions caused by different antigen-antibody systems. Microbiol Immunol. 1978;22(8):509-13. doi: 10.1111/j.1348-0421.1978.tb00398.x. No abstract available.
Reference Type
RESULT
Venkataraman A, Sieber JR, Schmidt AW, Waldron C, Theis KR, Schmidt TM. Variable responses of human microbiomes to dietary supplementation with resistant starch. Microbiome. 2016 Jun 29;4(1):33. doi: 10.1186/s40168-016-0178-x.
Reference Type
RESULT
Ze X, Duncan SH, Louis P, Flint HJ. Ruminococcus bromii is a keystone species for the degradation of resistant starch in the human colon. ISME J. 2012 Aug;6(8):1535-43. doi: 10.1038/ismej.2012.4. Epub 2012 Feb 16.
Reference Type
RESULT
Ze X, Ben David Y, Laverde-Gomez JA, Dassa B, Sheridan PO, Duncan SH, Louis P, Henrissat B, Juge N, Koropatkin NM, Bayer EA, Flint HJ. Unique Organization of Extracellular Amylases into Amylosomes in the Resistant Starch-Utilizing Human Colonic Firmicutes Bacterium Ruminococcus bromii. mBio. 2015 Sep 29;6(5):e01058-15. doi: 10.1128/mBio.01058-15.
Reference Type
RESULT
Mukhopadhya I, Morais S, Laverde-Gomez J, Sheridan PO, Walker AW, Kelly W, Klieve AV, Ouwerkerk D, Duncan SH, Louis P, Koropatkin N, Cockburn D, Kibler R, Cooper PJ, Sandoval C, Crost E, Juge N, Bayer EA, Flint HJ. Sporulation capability and amylosome conservation among diverse human colonic and rumen isolates of the keystone starch-degrader Ruminococcus bromii. Environ Microbiol. 2018 Jan;20(1):324-336. doi: 10.1111/1462-2920.14000. Epub 2017 Dec 7.
Reference Type
RESULT
Crost EH, Le Gall G, Laverde-Gomez JA, Mukhopadhya I, Flint HJ, Juge N. Mechanistic Insights Into the Cross-Feeding of Ruminococcus gnavus and Ruminococcus bromii on Host and Dietary Carbohydrates. Front Microbiol. 2018 Nov 5;9:2558. doi: 10.3389/fmicb.2018.02558. eCollection 2018.
Reference Type
RESULT
Cockburn DW, Koropatkin NM. Polysaccharide Degradation by the Intestinal Microbiota and Its Influence on Human Health and Disease. J Mol Biol. 2016 Aug 14;428(16):3230-3252. doi: 10.1016/j.jmb.2016.06.021. Epub 2016 Jul 6.
Reference Type
RESULT
Baxter NT, Schmidt AW, Venkataraman A, Kim KS, Waldron C, Schmidt TM. Dynamics of Human Gut Microbiota and Short-Chain Fatty Acids in Response to Dietary Interventions with Three Fermentable Fibers. mBio. 2019 Jan 29;10(1):e02566-18. doi: 10.1128/mBio.02566-18.
Reference Type
RESULT
Schiller LR. Chronic constipation: new insights, better outcomes? Lancet Gastroenterol Hepatol. 2019 Nov;4(11):873-882. doi: 10.1016/S2468-1253(19)30199-2.
Reference Type
RESULT
Chang L, Di Lorenzo C, Farrugia G, Hamilton FA, Mawe GM, Pasricha PJ, Wiley JW. Functional Bowel Disorders: A Roadmap to Guide the Next Generation of Research. Gastroenterology. 2018 Feb;154(3):723-735. doi: 10.1053/j.gastro.2017.12.010. Epub 2017 Dec 27.
Reference Type
RESULT
Annells M, Koch T. Older people seeking solutions to constipation: the laxative mire. J Clin Nurs. 2002 Sep;11(5):603-12. doi: 10.1046/j.1365-2702.2002.00626.x.
Reference Type
RESULT
Cardin F, Minicuci N, Droghi AT, Inelmen EM, Sergi G, Terranova O. Constipation in the acutely hospitalized older patients. Arch Gerontol Geriatr. 2010 May-Jun;50(3):277-81. doi: 10.1016/j.archger.2009.04.007. Epub 2009 May 28.
Reference Type
RESULT
Wallace C, Sinopoulou V, Gordon M, Akobeng AK, Llanos-Chea A, Hungria G, Febo-Rodriguez L, Fifi A, Fernandez Valdes L, Langshaw A, Saps M. Probiotics for treatment of chronic constipation in children. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD014257. doi: 10.1002/14651858.CD014257.pub2.
Reference Type
RESULT
Koloski NA, Jones M, Wai R, Gill RS, Byles J, Talley NJ. Impact of persistent constipation on health-related quality of life and mortality in older community-dwelling women. Am J Gastroenterol. 2013 Jul;108(7):1152-8. doi: 10.1038/ajg.2013.137. Epub 2013 May 14.
Reference Type
RESULT
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
Reference Type
RESULT
Tian H, Ding C, Gong J, Ge X, McFarland LV, Gu L, Wei Y, Chen Q, Zhu W, Li J, Li N. Treatment of Slow Transit Constipation With Fecal Microbiota Transplantation: A Pilot Study. J Clin Gastroenterol. 2016 Nov/Dec;50(10):865-870. doi: 10.1097/MCG.0000000000000472.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TJ-IRB20230956
Identifier Type: -
Identifier Source: org_study_id
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Fiber and Water Improve Bowel Habit in Humans
NCT02838849
COMPLETED
PHASE1/PHASE2
Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
NCT02140749
COMPLETED
NA
Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation
NCT02676388
UNKNOWN
PHASE2
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
NCT00306748
COMPLETED
PHASE2
Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
NCT01802112
COMPLETED
NA
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
NCT05151328
COMPLETED
PHASE3
Effectiveness and Safety of Probiotic in Regulating Chronic Constipation
NCT05980988
COMPLETED
NA
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals
NCT02649062
COMPLETED
PHASE1/PHASE2
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
NCT02281630
COMPLETED
PHASE2
Effect of scFOS on Increase in Stool Frequency in Constipated People
NCT03707002
COMPLETED
NA
Fecal Microbiota Transplantation for Constipation
NCT03308461
COMPLETED
NA
Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
NCT01540669
TERMINATED
NA
Efficacy of Interferential Therapy in Chronic Constipation (CON-COUR)
NCT02381665
UNKNOWN
NA
This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants
NCT06736912
NOT_YET_RECRUITING
PHASE1
Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
NCT06352827
COMPLETED
NA
Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
NCT07065942
RECRUITING
NA
Dietary Supplements for Reduction of Intestinal Permeability Levels
NCT06760377
NOT_YET_RECRUITING
NA
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
NCT07202481
RECRUITING
NA
Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
NCT04304170
COMPLETED
NA
Effect of Fecal Microbiota Transplantation in Slow Transit Constipation
NCT02301221
UNKNOWN
PHASE2