Effect of Modified Cellulose on Colonic Fermentation of Inulin

Irritable Bowel Syndrome Clinical Trial

— COCOA2  

Official title:

Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911347
• Other study ID #: FMHS 19-0622
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2023
• Source: University of Nottingham
• Contact: Joshua Read, PhD
• Phone: +44 115 9249924
• Email: joshua.read[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. We will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.

Description:

A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours.

Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring.

Secondary endpoint:

1. AUC (0-24h) breath hydrogen / methane

2. Oro-cecal transit time and whole gut transit time.

3. Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram

4. Effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.

The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses:

Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or older.

• 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 sampling period.

Exclusion Criteria:

• Pregnancy 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.

• Will not agree to dietary 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Psyllium
15g psyllium added to inulin solution to form a gel
• Methylcellulose
15 g methylcellulose added to inulin solution to form a gel
• Maltodextrin
15g maltodextrin added to inulin solution to form a gel

Locations

Country	Name	City	State
United Kingdom	University Hospital Clinical Research Centre	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath hydrogen	AUC 0-6 hours after ingestion	0-6 hoursafter ingestion
Secondary	Breath hydrogen	AUC 0-24 hours	0-24 hours post ingestion
Secondary	Breath methane	AUC 0-24 hours	0-24 hours post ingestion
Secondary	Transit time	whole gut transit time	Whole gut transit measured once before intervention