Effects of inulin and methylcellulose on gas production in the colon

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how chronic consumption of inulin, a fermentable fiber, combined with methylcellulose, a gel-forming fiber, affects colonic fermentation and gas production in patients with Irritable Bowel Syndrome (IBS). Participants will consume meals containing these fibers and their tolerance and symptoms will be monitored compared to a placebo. The goal is to determine if this combination can reduce symptoms like bloating and gas, which are common in IBS patients. Previous research has indicated that similar fibers may help alleviate these symptoms, and this study aims to explore the effectiveness of this specific combination.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Aged between 18 and 65 years old.

  * Able to give informed consent.
  * Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5).
  * Agrees to consume the meals provided.
  * Agrees to not smoke during the breath hydrogen sampling period.

Exclusion Criteria:

* • Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.

  * History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
  * Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
  * Intestinal stoma.
  * Any medical condition making participation potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances.
  * Has a body mass index (BMI) value less than 18.5 or greater than 35.
  * Will not agree to follow dietary and lifestyle restrictions required.
  * Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an exclusion criteria).
  * Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
  * Poor understanding of English language.
  * Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM.
  * Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g., cognitive dysfunction, chaotic lifestyle related to substance abuse.
  * Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.

Where it's running

• Nottingham Digestive Disease Centre
  Nottingham, Nottinghamshire, United Kingdom Recruiting
• Nottingham Digestive Diseases Centre
  Nottingham, Please Choose..., United Kingdom Recruiting

Study contacts

• Principal investigator: Robin C Spiller, MD — University of Nottingham
• Study coordinator: Alsion Thorpe, MD
• Email: alison.thorpe@nottingham.ac.uk
• Phone: +44 (0)115 7486731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.