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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05619341
Acronym
EON
Enrollment
17
Registered
2022-11-16
Start date
2022-10-28
Completion date
2023-04-01
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel

Keywords

fermentation, gas, colonic, inulin, psyllium

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.

Interventions

DIETARY_SUPPLEMENTpsyllium

psyllium 20g

DIETARY_SUPPLEMENTinulin

long chain fructan

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

psyllium / maltodextrin added to 500ml water + inulin 20g

Intervention model description

3 way cross-over

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hydrogen production2 daysAUC 0-24h

Secondary

MeasureTime frameDescription
Methane production2 daysAUC 0-24h
Intake of FOOMDAPS4 days24 h food diary X 4

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026