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Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON) (EON)

Primary Purpose

Irritable Bowel

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
psyllium
inulin
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 focused on measuring fermentation, gas, colonic, inulin, psyllium

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18 or older. Able to give informed consent. Scoring ≤3 (i.e., mild, or less) for symptoms of flatulence, bloating and abdominal pain 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 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 potentially compromising participation in the study e.g., type 1 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 nor consume the standard meals required during the study day. 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 they might alter 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

  • Nottingham Digestive Disease CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

inulin

inulin + psyllium

inulin divided doses

Arm Description

20g inulin in 500ml water

Inulin 20g + 20g psyllium in 500 ml water

2.5 g inulin in 62.5ml water given at 45 minute intervals

Outcomes

Primary Outcome Measures

Hydrogen production
AUC 0-24h

Secondary Outcome Measures

Methane production
AUC 0-24h
Intake of FOOMDAPS
24 h food diary X 4

Full Information

First Posted
November 1, 2022
Last Updated
November 15, 2022
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT05619341
Brief Title
Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON)
Acronym
EON
Official Title
Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham

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
To test whether slowing the rate of delivery of inulin with either psyllium or divided dosing of inulin, will reduce colonic gas production as compared to inulin combined with placebo. To obtain pilot data on link between habitual diet and fermentation of inulin.
Detailed Description
Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of fermentable oligo-di-mono-saccharides and polyhydric alcohols (FODMAPs). We have previously performed the study entitled the Effect of modified Cellulose On COlonic fermentAtion of inulin (COCOA) in which a modified methylcellulose (food grade product -modified celluloses- which can form gels at body temperature ) was used and showed some reduction, but this was not statistically significant, and much less than with psyllium. We wish to determine whether slowing delivery of inulin will produce a lowering of breath hydrogen equivalent to that seen with psyllium. We also found that the breath hydrogen curve had not shown a consistent fall by 6 hours suggesting that 6 hours was not long enough to accurately define the area under the curve (AUC). We now plan to use breath sampling bags to collect breath samples at home to define the breath hydrogen response over whole 24-hour period post ingestion of test drink. We also hypothesise that the colonic microbiota will influence the fermentation of inulin and will collect stool samples to allow future work to correlate microbiota with fermentation rates as part of a separate Medical Research Council funded study. Aim Our aim is to test the hypothesis that slowing delivery of inulin will achieve a similar reduction in breath hydrogen production over the 24 hours following ingestion as seen when co-administered with psyllium. Objective The primary objective is to compare the effect of bolus administration of inulin (co-administrated with psyllium or maltodextrin placebo) with divided dose delivery of inulin over 6 hours on total gas production over 24 hours. Secondary Objectives Secondary objectives will be 1) to compare breath hydrogen AUC 0-24h with values based on AUC 0-6h that was assessed in the previous study (COCOA) to see how much the shorter period underestimates H2 production; 2) to assess breath methane production AUC 0-24h after consumption of test drinks; and 3) to collect pilot data on habitual dietary FODMAPs intake to assess whether this alters fermentation of inulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel
Keywords
fermentation, gas, colonic, inulin, psyllium

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3 way cross-over
Masking
Participant
Masking Description
psyllium / maltodextrin added to 500ml water + inulin 20g
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inulin
Arm Type
Placebo Comparator
Arm Description
20g inulin in 500ml water
Arm Title
inulin + psyllium
Arm Type
Active Comparator
Arm Description
Inulin 20g + 20g psyllium in 500 ml water
Arm Title
inulin divided doses
Arm Type
Active Comparator
Arm Description
2.5 g inulin in 62.5ml water given at 45 minute intervals
Intervention Type
Dietary Supplement
Intervention Name(s)
psyllium
Intervention Description
psyllium 20g
Intervention Type
Dietary Supplement
Intervention Name(s)
inulin
Intervention Description
long chain fructan
Primary Outcome Measure Information:
Title
Hydrogen production
Description
AUC 0-24h
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Methane production
Description
AUC 0-24h
Time Frame
2 days
Title
Intake of FOOMDAPS
Description
24 h food diary X 4
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 or older. Able to give informed consent. Scoring ≤3 (i.e., mild, or less) for symptoms of flatulence, bloating and abdominal pain 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 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 potentially compromising participation in the study e.g., type 1 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 nor consume the standard meals required during the study day. 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 they might alter 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
Alaa Alhasein, BSc
Phone
01159249924
Email
ala.alhasein@nottingham.ac.uk
Facility Information:
Facility Name
Nottingham Digestive Disease 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
Alaa Alhasani, BSc
Phone
01159429924
Email
alyaa11@exmail.nottingham.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11820919
Citation
Galvin MA, Kiely M, Harrington KE, Robson PJ, Moore R, Flynn A. The North/South Ireland Food Consumption Survey: the dietary fibre intake of Irish adults. Public Health Nutr. 2001 Oct;4(5A):1061-8. doi: 10.1079/phn2001187.
Results Reference
result
PubMed Identifier
30046155
Citation
Dionne J, Ford AC, Yuan Y, Chey WD, Lacy BE, Saito YA, Quigley EMM, Moayyedi P. A Systematic Review and Meta-Analysis Evaluating the Efficacy of a Gluten-Free Diet and a Low FODMAPs Diet in Treating Symptoms of Irritable Bowel Syndrome. Am J Gastroenterol. 2018 Sep;113(9):1290-1300. doi: 10.1038/s41395-018-0195-4. Epub 2018 Jul 26.
Results Reference
result
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 Rate Of Delivery on Colonic Fermentation of inuliN (EON)

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