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

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psyllium
Methylcellulose
Maltodextrin
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome focused on measuring FODMAP (fermentable oligo-mono-di-saccharides and polyhydric alcohols, Inulin, Psyllium, Cellulose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital Clinical Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Psyllium

maltodextrin

Methylcellulose

Arm Description

Psyllium 15 g+ inulin 15 gm in 375ml water

Maltodextrin 15 g + inulin 15 gm in 375 ml water

Methylcellulose 15g + Inulin 15 g in 375 ml water

Outcomes

Primary Outcome Measures

Breath hydrogen
AUC 0-6 hours after ingestion

Secondary Outcome Measures

Breath hydrogen
AUC 0-24 hours
Breath methane
AUC 0-24 hours
Transit time
whole gut transit time

Full Information

First Posted
June 9, 2023
Last Updated
June 9, 2023
Sponsor
University of Nottingham
Collaborators
University of East Anglia
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1. Study Identification

Unique Protocol Identification Number
NCT05911347
Brief Title
Effect of Modified Cellulose on Colonic Fermentation of Inulin
Acronym
COCOA2
Official Title
Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
University of East Anglia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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: AUC (0-24h) breath hydrogen / methane Oro-cecal transit time and whole gut transit time. Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
FODMAP (fermentable oligo-mono-di-saccharides and polyhydric alcohols, Inulin, Psyllium, Cellulose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3 way cross-over
Masking
ParticipantOutcomes Assessor
Masking Description
Test meals will have similar appearance and flavour
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psyllium
Arm Type
Active Comparator
Arm Description
Psyllium 15 g+ inulin 15 gm in 375ml water
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin 15 g + inulin 15 gm in 375 ml water
Arm Title
Methylcellulose
Arm Type
Experimental
Arm Description
Methylcellulose 15g + Inulin 15 g in 375 ml water
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Intervention Description
15g psyllium added to inulin solution to form a gel
Intervention Type
Dietary Supplement
Intervention Name(s)
Methylcellulose
Intervention Description
15 g methylcellulose added to inulin solution to form a gel
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
15g maltodextrin added to inulin solution to form a gel
Primary Outcome Measure Information:
Title
Breath hydrogen
Description
AUC 0-6 hours after ingestion
Time Frame
0-6 hoursafter ingestion
Secondary Outcome Measure Information:
Title
Breath hydrogen
Description
AUC 0-24 hours
Time Frame
0-24 hours post ingestion
Title
Breath methane
Description
AUC 0-24 hours
Time Frame
0-24 hours post ingestion
Title
Transit time
Description
whole gut transit time
Time Frame
Whole gut transit measured once before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Read, PhD
Phone
+44 115 9249924
Email
joshua.read@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa AlHasani, BSc
Phone
+44 115 9249924
Email
luca.marciani@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin D Spiller, MD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Clinical Research Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
joshua Read, PhD
Email
joshua.read@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Alaa Alhasani, BSc
Ext
Spiller
Email
robin.spiller@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Robin C Spiller, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34353864
Citation
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(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.
Results Reference
result

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Effect of Modified Cellulose on Colonic Fermentation of Inulin

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