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

NCT03304041 | Completed DMC

• 1 other identifier: 20170116-2
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Diet Modification

Keywords

low-FODMAP; Irritable Bowel Syndrome; stool fermentation; Breath test

Outcome Measures

Primary Outcomes (1)

• Compare response to diet intervention between different groups.

  Primary endpoint will be response to 3-week of diet intervention defined by shows \>50 point reduction in IBS-SSS between baseline and post-intervention scores. The proportion of responders who met primary endpoint in each group will be compared.

  three weeks

Secondary Outcomes (12)

• Improvement in abdominal pain between different groups.

  Three weeks

• Improvement in stool consistency between different groups.

  Three weeks

• Compare changes from baseline in abdominal pain score between different groups.

  Every week, last for three weeks

• Compare changes from baseline in abdominal frequency between different groups.

  Every week, last for three weeks

• Compare changes from baseline in bloating score between different groups.

  Every week, last for three weeks

Other Outcomes (9)

• Compare group difference about stool fermentation production before and after intervention.

  Three weeks

• Compare group difference about fecal microbial α- diversity displayed by Shannon index before and after intervention.

  Three weeks

• Compare group difference about fecal microbial β- diversity displayed by Principal Component Analysis (PCA) before and after intervention.

  Three weeks

Study Arms (2)

low-FODMAPs diet

EXPERIMENTAL

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

Dietary Supplement: low-FODMAPs diet

Traditional dietary advice

PLACEBO COMPARATOR

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

Dietary Supplement: Traditional dietary advice

Interventions

low-FODMAPs diet 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

low-FODMAPs diet

Traditional dietary advice 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

Traditional dietary advice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Zhejiang Academy of Agricultural Sciences: collaborator
• University of Michigan: collaborator
• Klinik Arlesheim: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (1)

• 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.

  PMID: 33740048 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Yawen Zhang, MM

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Lijun Feng

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology department

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: October 6, 2017
• Study Start: October 10, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

CN (1)