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Clinical Trials/ISRCTN16562415
ISRCTN16562415
Completed
N/A

The impact of dietary interventions for irritable bowel syndrome on luminal microbiota, symptoms, nutrient intake and quality of life: a randomised controlled trial

King's College London0 sites69 target enrollmentMarch 23, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Irritable bowel syndrome
Sponsor
King's College London
Enrollment
69
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32433273/ results (added 07/08/2020)

Registry
who.int
Start Date
March 23, 2015
End Date
March 31, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Men and women aged 18\-65 years with diarrhoea\-predominant IBS (IBS\-D), mixed\-type IBS (IBS\-M) or unsubtyped IBS (IBS\-U) based on Rome III criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy and haemorrhoidectomy
  • 2\. Individuals able to give informed consent
  • 3\. Individuals naive to the dietary intervention

Exclusion Criteria

  • 1\. Females who report to be pregnant or lactating
  • 2\. Consumption of antibiotics, prebiotics or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study
  • 3\. Use of unpermitted medications
  • 4\. Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
  • 5\. Participants who have had changes to IBS medications or dose in the 4 weeks prior to the study
  • 6\. Less than 2 days of at least moderate abdominal pain or discomfort in the screening week
  • 7\. Individuals with additional specific dietary needs
  • 8\. Individuals with excess alcohol or caffeine intake as assessed by diet questionnaires as these substances may confound symptom results

Outcomes

Primary Outcomes

Not specified

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