Effect of MethylceIlulose or Psyllium on Fermentation of Inulin Assessed Using a Gas Sensing Capsule

NCT06551948 | Completed

• 1 other identifier: FMHS 64-1123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 colon. The investigators will achieve this using the Atmo pill, a recently developed ingestible gas-sensing wireless capsule manufactured by Atmo Biosciences. The pill is very similar in appearance and dimensions (26·8 mm long by 11·7 mm in diameter) to the Smart Pill, an FDA approved wireless capsule which measures local pH, which has been widely and safely used for over a decade. The Smart Pill is recommended for transit measurement by the American ACG Clinical Guidelines on Gastroparesis 3. The Atmo pill differs from the Smart Pill in measuring hydrogen and carbon dioxide within the colonic lumen rather than pH. The pill emits a radio signal to a small device worn by the participant to record the measurements periodically 4.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Colonic hydrogen per quarter of colonic transit

  mean hydrogen as % of colonic gas during the 4 quarters of colonic transit

  up to 4 days

Secondary Outcomes (1)

• carbon dioxide gas production

  up to 4 days

Other Outcomes (2)

• Breath hydrogen

  0-6 hours

• Regional transit times (hours) of Atmo pill;

  up to 4 days

Study Arms (3)

Psyllium

EXPERIMENTAL

15 g psyllium

Dietary Supplement: psyllium; Dietary Supplement: inulin

methylcellulose

EXPERIMENTAL

15 g methylcellulose

Dietary Supplement: methylcellulose; Dietary Supplement: inulin

Maltodextrin

PLACEBO COMPARATOR

15 g maltodextrin

Dietary Supplement: maltodextrin; Dietary Supplement: inulin

Interventions

psyllium DIETARY_SUPPLEMENT

15 g psyllium

Psyllium

methylcellulose DIETARY_SUPPLEMENT

15 gm methylcellulose

methylcellulose

maltodextrin DIETARY_SUPPLEMENT

15 g maltodextrin

Maltodextrin

inulin DIETARY_SUPPLEMENT

15g inulin

Maltodextrin; Psyllium; methylcellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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. -

Sponsors & Collaborators

• University of Nottingham: lead
• University of East Anglia: collaborator

Study Sites (1)

Nottingham Digestive Disease Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psyllium; Methylcellulose; maltodextrin; Inulin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Cellulose; Glucans; Polysaccharides; Carbohydrates; Starch; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Fructans

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Test meals in opaque plastic bags
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: 3 way cross over

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)