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

NCT03304041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-09-12

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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

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

Sponsors & Collaborators

  • Zhejiang Academy of Agricultural Sciences

    collaborator UNKNOWN

  • University of Michigan

    collaborator OTHER

  • Klinik Arlesheim

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Yawen Zhang, MM · Sir Run Run Shaw Hospital

  • Lijun Feng · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-05-31
Completion
2019-05-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304041 on ClinicalTrials.gov