Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
NCT ID: NCT06420843
Last Updated: 2024-05-20
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-12-22
Study Completion Date
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Intervention:
(Weeks 1-2, Visit 3-4) - Starting from the second week after the date of consent, patients with IBS will be randomized 1:1 into two groups. The first group (20 patients) will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans. The second group (20 patients) will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk. The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight. After the second week, the metabolome and physical characteristics. The enrollment period will last for one year. The analysis of clinical data will be completed within one year after patient enrollment. Analysis of laboratory data will be performed in parallel.
(Weeks 1-2, Visit 3-4) - Starting from the second week after the date of consent, patients with IBS will be randomized 1:1 into two groups. The first group (20 patients) will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans. The second group (20 patients) will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk. The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight. After the second week, the metabolome and physical characteristics. The enrollment period will last for one year. The analysis of clinical data will be completed within one year after patient enrollment. Analysis of laboratory data will be performed in parallel.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low FODMAPs Diet in Gastrointestinal Disorders
NCT03644602
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Coeliac Disease
COMPLETED
NA
The Effects of FODMAPs in Patients With Irritable Bowel Syndrome
NCT05182593
Irritable Bowel Syndrome
COMPLETED
NA
The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome
NCT04307368
Irritable Bowel Syndrome
COMPLETED
NA
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
NCT04373304
Irritable Bowel Syndrome
FODMAP
UNKNOWN
NA
Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
NCT02107625
Irritable Bowel Syndrome
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Irritable bowel syndrome (IBS) is a chronic intestinal condition whose high incidence and prevalence make it a major healthcare problem(3-7). IBS affects 7-15% of the general population(6, 7). It is twice as frequent in women(8) and is diagnosed more often in patients less than 50 years of age(9). It is characterized by recurrent episodes of functional gastrointestinal symptoms whose pathophysiological mechanisms are not completely clear(10). The most common symptoms include abdominal pain, bloating, constipation, and/or diarrhea(10). IBS negatively impacts quality of life and causes a substantial burden on healthcare resources(11, 12). Like the clinical phenotypes, the pathophysiological mechanisms underlying the syndrome are heterogeneous and not fully understood(13). However, there is evidence that IBS may result from a combination of gastrointestinal motility changes, visceral hypersensitivity, low-grade inflammation, altered microbiota, and food components(14-17). Due to the diversity of IBS symptoms and their considerable variability over time, a wide range of pharmacological treatments are employed which often only target the primary symptom; thus, when multiple symptoms are present, the treatments administered are often inadequate. This has led to the investigation of use of dietary therapies as a treatment option.
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS. An increasing number of uncontrolled and controlled trials have examined the clinical effectiveness of a low FODMAP diet in patients with IBS using either dietary advice or feeding protocols. Uncontrolled and unblinded controlled trials suggest symptom response rates in patients with IBS are as high as 85%(18). Similarly, a beneficial impact on symptoms has been reported in blinded randomized controlled trials(19-22). A potential shortcoming of the low FODMAP diet and of any diet that involves multiple food exclusion, is the risk of nutritional inadequacy, and this is especially pertinent if the excluded foods are nutrient-rich. The low FODMAP diet requires substitution of selected food items across a number of food groups and, therefore, there is the potential for inadequate intake of nutrients, particularly carbohydrate, fiber, iron, B vitamins, and calcium. Another potential safety concern associated with implementation of the diet relates to the impact on the gastrointestinal microbiota, which has been implicated in the pathogenesis of IBS(23) and has been associated with clinical features of IBS including abdominal pain, anxiety, and depression(24, 25). Hence, we propose to evaluate the microbiome and metabolome in IBS patients to create datasets of integrated data through AI tools. Furthermore, we aim to determine the effects of a low FOODMAP diet based on fermented products on the microbiome and metabolome in IBS patients. These evaluations will allow to assess patient's nutrient deficiency and the general quality of life pre and post intervention among groups and to develop a personalized treatment that will increase the quality of life in IBS patients.
The low FODMAPs diet is associated with limitations particularly due to the elimination of several food items which can cause worsening of the side effects due to significant alteration of the intestinal microbiota composition and an overall reduction of the nutritional status. Although, probiotics seem to have beneficial effects on improving this side effect, their way of function is still relatively unknown. Much remains to be answered as to which strains is/are most effective across the broad spectrum of IBS patients and whether single or combination of strains work best. This leads to the question of whether individual differences among IBS patients in terms of microbiome diversity could affect the efficacy of probiotics therapy. Therefore, with our approach we propose a reshaping of the host-microbiota interactions through personalized nutrition which could be a new therapeutic avenue for both disease control and prevention. Specifically, we believe that a diet supplemented with previously fermented food items will be beneficial for the patient's condition. This fermentation will be controlled and performed with Lactobacillus paracasei strain CNCM I-5220. Through the longitudinal study we will be able to evaluate their grade of the disorder at baseline (one week of low FODMAP diet), and the effect of the fermented food items on their microbiota and metabolome after one and two weeks. Furthermore, by adopting new efficacious treatment options, it might be possible to decrease the high recurrence rate of IBS patients to the public health system, improving patient's quality of life and decreasing the costs for the National Sanitary System (SSN).
The primary objective will be to assess the enterotypes of IBS patient at baseline and to analyze how supplementation of fermented food modifies the microbiome and metabolome in IBS patients following a low FODMAP diet.
As secondary objective, we will compare the efficacy and safety of two different nutritional approaches on IBS symptoms.
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS. An increasing number of uncontrolled and controlled trials have examined the clinical effectiveness of a low FODMAP diet in patients with IBS using either dietary advice or feeding protocols. Uncontrolled and unblinded controlled trials suggest symptom response rates in patients with IBS are as high as 85%(18). Similarly, a beneficial impact on symptoms has been reported in blinded randomized controlled trials(19-22). A potential shortcoming of the low FODMAP diet and of any diet that involves multiple food exclusion, is the risk of nutritional inadequacy, and this is especially pertinent if the excluded foods are nutrient-rich. The low FODMAP diet requires substitution of selected food items across a number of food groups and, therefore, there is the potential for inadequate intake of nutrients, particularly carbohydrate, fiber, iron, B vitamins, and calcium. Another potential safety concern associated with implementation of the diet relates to the impact on the gastrointestinal microbiota, which has been implicated in the pathogenesis of IBS(23) and has been associated with clinical features of IBS including abdominal pain, anxiety, and depression(24, 25). Hence, we propose to evaluate the microbiome and metabolome in IBS patients to create datasets of integrated data through AI tools. Furthermore, we aim to determine the effects of a low FOODMAP diet based on fermented products on the microbiome and metabolome in IBS patients. These evaluations will allow to assess patient's nutrient deficiency and the general quality of life pre and post intervention among groups and to develop a personalized treatment that will increase the quality of life in IBS patients.
The low FODMAPs diet is associated with limitations particularly due to the elimination of several food items which can cause worsening of the side effects due to significant alteration of the intestinal microbiota composition and an overall reduction of the nutritional status. Although, probiotics seem to have beneficial effects on improving this side effect, their way of function is still relatively unknown. Much remains to be answered as to which strains is/are most effective across the broad spectrum of IBS patients and whether single or combination of strains work best. This leads to the question of whether individual differences among IBS patients in terms of microbiome diversity could affect the efficacy of probiotics therapy. Therefore, with our approach we propose a reshaping of the host-microbiota interactions through personalized nutrition which could be a new therapeutic avenue for both disease control and prevention. Specifically, we believe that a diet supplemented with previously fermented food items will be beneficial for the patient's condition. This fermentation will be controlled and performed with Lactobacillus paracasei strain CNCM I-5220. Through the longitudinal study we will be able to evaluate their grade of the disorder at baseline (one week of low FODMAP diet), and the effect of the fermented food items on their microbiota and metabolome after one and two weeks. Furthermore, by adopting new efficacious treatment options, it might be possible to decrease the high recurrence rate of IBS patients to the public health system, improving patient's quality of life and decreasing the costs for the National Sanitary System (SSN).
The primary objective will be to assess the enterotypes of IBS patient at baseline and to analyze how supplementation of fermented food modifies the microbiome and metabolome in IBS patients following a low FODMAP diet.
As secondary objective, we will compare the efficacy and safety of two different nutritional approaches on IBS symptoms.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
IBS - Irritable Bowel Syndrome
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
low FODMAP milk
Patients will receive one week of low FODMAP diet supplemented with fermented milk followed by one week of low FODMAP diet supplemented with fermented beans.
Group Type
EXPERIMENTAL
FOODMAP
Intervention Type
DIETARY_SUPPLEMENT
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS.
low FODMAP beans
The second group will receive low FODMAP diet supplemented for one week with fermented beans followed by a second week of low FODMAP diet supplemented with fermented milk.
Group Type
ACTIVE_COMPARATOR
FOODMAP
Intervention Type
DIETARY_SUPPLEMENT
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FOODMAP
Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients of both sex and any race
* Age ≥18 and ≤70.
* IBS confirmed by Rome IV diagnostic criteria
* Willing to adhere to the proposed diet
* Provision of written informed consent
* Commitment of availability throughout the study period
* Age ≥18 and ≤70.
* IBS confirmed by Rome IV diagnostic criteria
* Willing to adhere to the proposed diet
* Provision of written informed consent
* Commitment of availability throughout the study period
Exclusion Criteria
* Patient age \<18 and \> 70
* Diabetes (Type 1 or 2)
* Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening.
* Pregnant or planning to become pregnant or is lactating.
* History of HIV or hepatitis B or C
* Participation in investigational study within past 30 days
* Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition
* Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
* Diabetes (Type 1 or 2)
* Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening.
* Pregnant or planning to become pregnant or is lactating.
* History of HIV or hepatitis B or C
* Participation in investigational study within past 30 days
* Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition
* Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Clinico Humanitas
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, Italy
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Italy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
Reference Type
BACKGROUND
Gibson PR, Shepherd SJ. Evidence-based dietary management of functional gastrointestinal symptoms: The FODMAP approach. J Gastroenterol Hepatol. 2010 Feb;25(2):252-8. doi: 10.1111/j.1440-1746.2009.06149.x.
Reference Type
BACKGROUND
Altobelli E, Lattanzi A, Paduano R, Varassi G, di Orio F. Colorectal cancer prevention in Europe: burden of disease and status of screening programs. Prev Med. 2014 May;62:132-41. doi: 10.1016/j.ypmed.2014.02.010. Epub 2014 Feb 14.
Reference Type
BACKGROUND
Altobelli E, D'Aloisio F, Angeletti PM. Colorectal cancer screening in countries of European Council outside of the EU-28. World J Gastroenterol. 2016 May 28;22(20):4946-57. doi: 10.3748/wjg.v22.i20.4946.
Reference Type
BACKGROUND
Burisch J, Jess T, Martinato M, Lakatos PL; ECCO -EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013 May;7(4):322-37. doi: 10.1016/j.crohns.2013.01.010. Epub 2013 Feb 8.
Reference Type
BACKGROUND
American College of Gastroenterology Task Force on Irritable Bowel Syndrome; Brandt LJ, Chey WD, Foxx-Orenstein AE, Schiller LR, Schoenfeld PS, Spiegel BM, Talley NJ, Quigley EM. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009 Jan;104 Suppl 1:S1-35. doi: 10.1038/ajg.2008.122. No abstract available.
Reference Type
BACKGROUND
Andrews EB, Eaton SC, Hollis KA, Hopkins JS, Ameen V, Hamm LR, Cook SF, Tennis P, Mangel AW. Prevalence and demographics of irritable bowel syndrome: results from a large web-based survey. Aliment Pharmacol Ther. 2005 Nov 15;22(10):935-42. doi: 10.1111/j.1365-2036.2005.02671.x.
Reference Type
BACKGROUND
Muller-Lissner SA, Bollani S, Brummer RJ, Coremans G, Dapoigny M, Marshall JK, Muris JW, Oberndorff-Klein Wolthuis A, Pace F, Rodrigo L, Stockbrugger R, Vatn MH. Epidemiological aspects of irritable bowel syndrome in Europe and North America. Digestion. 2001;64(3):200-4. doi: 10.1159/000048862.
Reference Type
BACKGROUND
El-Salhy M, Gundersen D, Gilja OH, Hatlebakk JG, Hausken T. Is irritable bowel syndrome an organic disorder? World J Gastroenterol. 2014 Jan 14;20(2):384-400. doi: 10.3748/wjg.v20.i2.384.
Reference Type
BACKGROUND
Horwitz BJ, Fisher RS. The irritable bowel syndrome. N Engl J Med. 2001 Jun 14;344(24):1846-50. doi: 10.1056/NEJM200106143442407. No abstract available.
Reference Type
BACKGROUND
Chang L. Review article: epidemiology and quality of life in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004 Nov;20 Suppl 7:31-9. doi: 10.1111/j.1365-2036.2004.02183.x.
Reference Type
BACKGROUND
Maxion-Bergemann S, Thielecke F, Abel F, Bergemann R. Costs of irritable bowel syndrome in the UK and US. Pharmacoeconomics. 2006;24(1):21-37. doi: 10.2165/00019053-200624010-00002.
Reference Type
BACKGROUND
Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954.
Reference Type
BACKGROUND
Anastasi JK, Capili B, Chang M. Managing irritable bowel syndrome. Am J Nurs. 2013 Jul;113(7):42-52; quiz 54, 53. doi: 10.1097/01.NAJ.0000431911.65473.35.
Reference Type
BACKGROUND
Mayer EA. Clinical practice. Irritable bowel syndrome. N Engl J Med. 2008 Apr 17;358(16):1692-9. doi: 10.1056/NEJMcp0801447.
Reference Type
BACKGROUND
Mayer EA, Labus JS, Tillisch K, Cole SW, Baldi P. Towards a systems view of IBS. Nat Rev Gastroenterol Hepatol. 2015 Oct;12(10):592-605. doi: 10.1038/nrgastro.2015.121. Epub 2015 Aug 25.
Reference Type
BACKGROUND
Rajilic-Stojanovic M, Jonkers DM, Salonen A, Hanevik K, Raes J, Jalanka J, de Vos WM, Manichanh C, Golic N, Enck P, Philippou E, Iraqi FA, Clarke G, Spiller RC, Penders J. Intestinal microbiota and diet in IBS: causes, consequences, or epiphenomena? Am J Gastroenterol. 2015 Feb;110(2):278-87. doi: 10.1038/ajg.2014.427. Epub 2015 Jan 27.
Reference Type
BACKGROUND
Staudacher HM, Irving PM, Lomer MC, Whelan K. Mechanisms and efficacy of dietary FODMAP restriction in IBS. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):256-66. doi: 10.1038/nrgastro.2013.259. Epub 2014 Jan 21.
Reference Type
BACKGROUND
Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.
Reference Type
BACKGROUND
Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
Reference Type
BACKGROUND
Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
Reference Type
BACKGROUND
Eswaran SL, Chey WD, Han-Markey T, Ball S, Jackson K. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. Am J Gastroenterol. 2016 Dec;111(12):1824-1832. doi: 10.1038/ajg.2016.434. Epub 2016 Oct 11.
Reference Type
BACKGROUND
Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
Reference Type
BACKGROUND
Sundin J, Rangel I, Fuentes S, Heikamp-de Jong I, Hultgren-Hornquist E, de Vos WM, Brummer RJ. Altered faecal and mucosal microbial composition in post-infectious irritable bowel syndrome patients correlates with mucosal lymphocyte phenotypes and psychological distress. Aliment Pharmacol Ther. 2015 Feb;41(4):342-51. doi: 10.1111/apt.13055. Epub 2014 Dec 18.
Reference Type
BACKGROUND
Parkes GC, Rayment NB, Hudspith BN, Petrovska L, Lomer MC, Brostoff J, Whelan K, Sanderson JD. Distinct microbial populations exist in the mucosa-associated microbiota of sub-groups of irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jan;24(1):31-9. doi: 10.1111/j.1365-2982.2011.01803.x. Epub 2011 Nov 9.
Reference Type
BACKGROUND
Pasolli E, Truong DT, Malik F, Waldron L, Segata N. Machine Learning Meta-analysis of Large Metagenomic Datasets: Tools and Biological Insights. PLoS Comput Biol. 2016 Jul 11;12(7):e1004977. doi: 10.1371/journal.pcbi.1004977. eCollection 2016 Jul.
Reference Type
BACKGROUND
Troisi J, Sarno L, Landolfi A, Scala G, Martinelli P, Venturella R, Di Cello A, Zullo F, Guida M. Metabolomic Signature of Endometrial Cancer. J Proteome Res. 2018 Feb 2;17(2):804-812. doi: 10.1021/acs.jproteome.7b00503. Epub 2018 Jan 2.
Reference Type
BACKGROUND
Bar-Joseph Z, Gifford DK, Jaakkola TS. Fast optimal leaf ordering for hierarchical clustering. Bioinformatics. 2001;17 Suppl 1:S22-9. doi: 10.1093/bioinformatics/17.suppl_1.s22.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
NCT03687814
RECRUITING
NA
Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome
NCT02565550
UNKNOWN
PHASE4
Effect of a Low- Fermentable-Oligo-Di- Monosaccharides and Polyols Diet Group Intervention on IBS Symptoms and Fatigue
NCT05124262
NOT_YET_RECRUITING
NA
Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome
NCT04364750
UNKNOWN
EARLY_PHASE1
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
NCT02980406
COMPLETED
NA
Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity
NCT04662502
COMPLETED
Intracolonic FODMAP Infusion in Healthy Volunteers
NCT06488534
COMPLETED
NA
Effect of FODMAPs on Mucosal Inflammation in IBS Patients
NCT03221790
UNKNOWN
NA
Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant
NCT03423069
COMPLETED
NA
(FODMAP) Diet on Improving Symptoms of Patients With Irritable Bowel Syndrome
NCT07299305
COMPLETED
NA
A Clinical Trial Evaluating Diets for IBS
NCT05831306
UNKNOWN
NA
Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
NCT04236843
COMPLETED
NA
The Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota
NCT02259465
COMPLETED
NA
Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome
NCT04283487
COMPLETED
NA
Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
NCT02210572
COMPLETED
NA
Effects of Low FODMAP Diet on Leaky Gut
NCT04526808
COMPLETED
NA
Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients
NCT05144204
UNKNOWN
NA
Effect of a Low FODMAP Diet in IBS and Functional Constipation with Bloating: a Randomized Double-Blind Trial
NCT06871748
NOT_YET_RECRUITING
NA
Nutrition to Relieve IBS Symptoms by Targeting the Microbiota
NCT04790422
COMPLETED
NA
Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients
NCT05326646
TERMINATED
NA
Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
NCT06749613
RECRUITING
NA
The Effects of Carbohydrates in Irritable Bowel Syndrome
NCT04830410
COMPLETED
NA
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
NCT04542018
COMPLETED
NA
Microbiota Profiling in IBS
NCT03720314
COMPLETED
Dose-dependent FODMAP Reintroduction in IBS
NCT05808023
RECRUITING
NA