Status:
COMPLETED
Effect of MethylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
University of East Anglia
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators plan to measure the local (in vivo) production of hydrogen when methylcellulose is ingested, to see if the investigators can show a shift of the site of fermentation to the distal co...
Detailed Description
Aim This pilot study aims to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will delay colonic fermentation compared to inulin combined with placebo (maltod...
Eligibility Criteria
Inclusion
- 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
- 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.
- Contraindications to Atmo capsule including swallowing disorders, suspected or known strictures or GI surgery within last 3 months or consuming Proton Pump Inhibitors (full details see Atmo manual)
- For any reason, unable to wear or maintain close proximity to (no greater than 1.5 m) the personal receiver which logs the data measured from the Atmo pill for the duration of its whole gut transit.
- 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. -
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06551948
Start Date
January 1 2024
End Date
June 30 2024
Last Update
April 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nottingham Digestive Disease Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH