Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in China
Condition: Irritable Bowel Syndrome; Diet Modification
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): low-FODMAPs diet; Traditional dietary advice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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(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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low-FODMAP; Irritable Bowel Syndrome; stool fermentation; Breath test