Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in China

NCT ID: NCT03304041

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2019-05-31

Brief Summary

The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from tertiary hospitals in China. Secondary aims of this research include an analysis of clinical, physiological and microbiological factors that may predict IBS patient response to this dietary intervention.

Detailed Description

Visit 1：Enrollment & Screening & Run-in period Patients who meet the inclusion criteria will be asked to complete IBS Baseline Assessment Questionnaires according to Rome III.Subjects that meet the criteria will receive verbal and written information about the study and provide written informed consent. After meeting with the dietitian and physician who will provide instructions, they will be asked to complete Combined Nutrient and Lactulose Breath Test.[16] Additionally, a baseline food and symptom diary will be completed in a (minimum) 14 day run-in period after breath test (the first 48hr after the breath test will not be included in this analysis). This diary record prior to the intervention will document baseline symptom severity and capture the habitual diet of IBS patients.

Visit 2: Randomization & Intervention. After the run-in period, patients will come back to the clinic to receive dietary instruction ahead of starting the intervention. At the same visit subjects will provide fresh stool for fermentation analysis (including short chain fatty acids and pressure detection) and blood for cytokines analysis. Subjects will then be randomly assigned to either low FODMAP diet (LFD) group or traditional dietary advice for IBS (TDA) group by computer-generated random number table. Participants will receive food instructions by a dietitian, according to their assignment. Throughout the study, only the dietitian will be aware of the assignment of the intervention given. Both diet therapy will last for 3 weeks, and all the subjects are instructed to complete daily food and symptom diary through a provided booklet. IBS Symptoms Severity Scores (IBS-SSS) is evaluated every week and the dietitian who is not aware of the allocation will make a telephone follow-up to assess patient adherence.

Visit 3: End of treatment & Follow-up. After 3 weeks of intervention, the participants will attend a follow-up appointment and complete the IBS Post-Intervention Assessment Questionnaires. Fresh stools and blood are recollected at this visit to evaluate for possible change in gut microbiota and cytokines after diet intervention.

Conditions

Irritable Bowel Syndrome; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

low-FODMAPs diet

The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.

low-FODMAPs diet therapy for 3 weeks

Group Type: EXPERIMENTAL

low-FODMAPs diet

Intervention Type: DIETARY_SUPPLEMENT

The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.

low-FODMAPs diet therapy for 3 weeks

Traditional dietary advice

Traditional dietary advice (TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period

Traditional dietary advice for 3 weeks

Group Type: PLACEBO_COMPARATOR

Traditional dietary advice

Intervention Type: DIETARY_SUPPLEMENT

Traditional dietary advice(TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period

traditional dietary advice for 3 weeks

Interventions

low-FODMAPs diet

The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.

low-FODMAPs diet therapy for 3 weeks

Intervention Type: DIETARY_SUPPLEMENT

Traditional dietary advice

Traditional dietary advice(TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period

traditional dietary advice for 3 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 18-65 years old.
• Meet Rome Rome III criteria for IBS-D.
• All these patients should have no abnormality in blood, stool analysis or colonoscopy within the previous 2 years.
• No GI alarm symptoms.

Exclusion Criteria

• Presence of a severe cardiac, hepatic, nephritic, neurologic disease.
• Presence of mental disorders caused by schizophrenia, organic brain disorder or physical disease.
• Other comorbid medical conditions (eg.unstable diabetes, unstable thyroid disease).
• Previous abdominal surgery except appendectomy or hysterectomy.
• Pregnant or lactating women.
• Use of probiotics, prebiotics, lactulose, antidiarrheal agents or bowel preparation within the 4 weeks prior to the study.
• Participation in any other form of dietary therapy within the 4 weeks prior to the study.
• Difficulties in communication.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Academy of Agricultural Sciences

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Klinik Arlesheim

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

DAI Ning

Director of Gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yawen Zhang, MM

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Lijun Feng

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

Zhang Y, Feng L, Wang X, Fox M, Luo L, Du L, Chen B, Chen X, He H, Zhu S, Hu Z, Chen S, Long Y, Zhu Y, Xu L, Deng Y, Misselwitz B, Lang BM, Yilmaz B, Kim JJ, Owyang C, Dai N. Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet compared with traditional dietary advice for diarrhea-predominant irritable bowel syndrome: a parallel-group, randomized controlled trial with analysis of clinical and microbiological factors associated with patient outcomes. Am J Clin Nutr. 2021 Jun 1;113(6):1531-1545. doi: 10.1093/ajcn/nqab005.

Reference Type: DERIVED

PMID: 33740048 (View on PubMed)

Other Identifiers

20170116-2

Identifier Type: -

Identifier Source: org_study_id