Effect of Modified Cellulose on Colonic Fermentation of Inulin

Conditions

Irritable Bowel Syndrome

Keywords

FODMAP, Inulin, Psyllium, Cellulose

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. The investigators 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: 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

Reid JESJ, Alhasani AT, MacCalman T, Amor D, Aliyu AI, Modasia AA, Harris H, Warren FJ, Hoad C, Gowland PA, Yakubov GE, Crooks C, Corsetti M, Marciani L, Spiller RC.

2026-02-23

10.1039/d5fo03532e

Interventions

DIETARY_SUPPLEMENTPsyllium

15g psyllium added to inulin solution to form a gel

DIETARY_SUPPLEMENTMethylcellulose

15 g methylcellulose added to inulin solution to form a gel

DIETARY_SUPPLEMENTMaltodextrin

15g maltodextrin added to inulin solution to form a gel

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Test meals will have similar appearance and flavour

Intervention model description

3 way cross-over

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Breath hydrogen	0-6 hoursafter ingestion	AUC 0-6 hours after ingestion

Secondary

Measure	Time frame	Description
Breath hydrogen	0-24 hours post ingestion	AUC 0-24 hours
Breath methane	0-24 hours post ingestion	AUC 0-24 hours
Transit time	Whole gut transit measured once before intervention	whole gut transit time

Countries

United Kingdom

Outcome results

None listed