Pre-FIBRe Study: Predeterminants of Fibre Induced Bloating Response.

NCT04802798 | Completed

• 1 other identifier: HR-19/20-18704
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an exploratory study aimed at gaining a greater understanding of the cause of abdominal bloating in response to two distinct fibre types. This is a single-center, interventional double blinded randomized cross-over study. Each participant will consume each of the study products (placebo, fibre 1 and fibre 2) for a 7-day period with a 3-week washout period in between. Outcomes will be measured before and after each intervention period.

Conditions

Functional Bloating (Disorder)

Outcome Measures

Primary Outcomes (3)

• Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of first intervention period (day 7)

  As this is an exploratory study to determine the underlying mechanisms of bloating the investigators have identified a primary and secondary symptom responder definition (those that become bloated in response to the intervention) that will be used to examine and compare the research outcome measures. The primary responder definition is: reporting moderate or severe bloating (a score of 2 or 3) on at least two of the final three days of the fibre-1 or fibre-2 challenge, measured using the Gastrointestinal Symptoms Rating Scale (GSRS), which rates individual gastrointestinal symptoms on a 4-point Likert scale (0-3). The primary responder definition of response will also be measured at the end of the placebo period.

  Day 7

• Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of second intervention period (day 35)

  As this is an exploratory study to determine the underlying mechanisms of bloating the investigators have identified a primary and secondary symptom responder definition (those that become bloated in response to the intervention) that will be used to examine and compare the research outcome measures. The primary responder definition is: reporting moderate or severe bloating (a score of 2 or 3) on at least two of the final three days of the fibre-1 or fibre-2 challenge, measured using the Gastrointestinal Symptoms Rating Scale (GSRS), which rates individual gastrointestinal symptoms on a 4-point Likert scale (0-3). The primary responder definition of response will also be measured at the end of the placebo period.

  Day 35

• Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of third intervention period (day 63)

  As this is an exploratory study to determine the underlying mechanisms of bloating the investigators have identified a primary and secondary symptom responder definition (those that become bloated in response to the intervention) that will be used to examine and compare the research outcome measures. The primary responder definition is: reporting moderate or severe bloating (a score of 2 or 3) on at least two of the final three days of the fibre-1 or fibre-2 challenge, measured using the Gastrointestinal Symptoms Rating Scale (GSRS), which rates individual gastrointestinal symptoms on a 4-point Likert scale (0-3). The primary responder definition of response will also be measured at the end of the placebo period.

  Day 63

Secondary Outcomes (12)

• Secondary response measure: Adequate relief of bloating symptoms assessed by the Global Symptom Questionnaire (GSQ) (Secondary clinical response)

  Day 7, day 21, day 28, day 35, day 56, day 63

• Clinical profile: Gas-related gastrointestinal symptom profile assessed by the Intestinal Gas Questionnaire (IGQ)

  Gas-related gastrointestinal symptom profile will be assessed after each intervention period (days 7, 35 and 63) and after each washout period (days 28 and 56) and once at a control timepoint (day 21).

• Clinical profile: Gastrointestinal symptom profile assessed by the Gastrointestinal symptom rating scale (GSRS)

  Gastrointestinal symptoms profile will be assessed after each intervention period (days 7, 35 and 63) and after each washout period (days 28 and 56) and once at a control timepoint (day 21).

• Clinical profile: Stool form and frequency using the Bristol Stool Form Scale (BSFS)

  The BSFS for each stool passed will be recorded in a 7-day diary and will be assessed after each intervention period (days 7, 35 and 63) and after each washout period (days 28 and 56) and once at a control timepoint (day 21).

• Clinical profile: Abdominal girth (cms)

  Abdominal girth will be recorded daily in a 7-day diary and will be assessed after each intervention period (days 7, 35 and 63) and after each washout period (days 28 and 56) and once at a control timepoint (day 21).

Other Outcomes (1)

• Exploratory analysis of secondary outcome measures 5-15 (listed above)

  Days 7, 21, 28, 35, 56, and 63

Study Arms (2)

Placebo, Fibre 1, Fibre 2

EXPERIMENTAL

All three interventions will be provided in a randomized double-blind order. The interventions will consist of 8 grams per day of three different types of powdered food supplement that will be mixed with water and consumed for a 7-day period. The powdered food supplement will be either placebo (glucose), fibre 1 (derived from a plant-based food) or fibre 2 (derived from a different plant-based food).

Dietary Supplement: Fibre 1; Dietary Supplement: Fibre 2; Dietary Supplement: Placebo

Placebo, Fibre 2, Fibre 1

EXPERIMENTAL

All three interventions will be provided in a randomized double-blind order. The interventions will consist of 8 grams per day of three different types of powdered food supplement that will be mixed with water and consumed for a 7-day period. The powdered food supplement will be either placebo (glucose), fibre 1 (derived from a plant-based food) or fibre 2 (derived from a different plant-based food).

Dietary Supplement: Fibre 1; Dietary Supplement: Fibre 2; Dietary Supplement: Placebo

Interventions

Fibre 1 DIETARY_SUPPLEMENT

Food derived fibre presented as a white powder

Placebo, Fibre 1, Fibre 2; Placebo, Fibre 2, Fibre 1

Fibre 2 DIETARY_SUPPLEMENT

Food derived fibre presented as a white powder

Placebo, Fibre 1, Fibre 2; Placebo, Fibre 2, Fibre 1

Placebo DIETARY_SUPPLEMENT

Simple sugar, presented as a white powder

Placebo, Fibre 1, Fibre 2; Placebo, Fibre 2, Fibre 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults (18-60 years of age inclusive, and BMI 19-29 kg/m2 inclusive) who fulfil criteria for functional bloating as per Rome IV Criteria (to be assessed at screening phone call).
• Individuals willing to provide consent and follow the protocol
• Individuals who report that due to perceived trigger food avoidance, symptoms are well controlled i.e. report that over the past 3 days they have had absent or mild bloating on ≥2 days.
• Individuals that do not fulfil Rome IV criteria for irritable bowel syndrome, functional constipation or functional diarrhoea
• Individuals that report heightened bloating in response to foods predominantly high in just one type of study fibre i.e not those that report bloating in response to foods high in both. The goal will be to recruit equal proportion of each.
• Individuals that are not diagnosed with any other chronic gastrointestinal disease or condition including inflammatory bowel disease, coeliac disease.

You may not qualify if:

• \. Excessive habitual intake of fructans, galacto-oligosaccharides, polyols or fructose, as defined by clinician as the sole cause of symptoms.
• \. Individuals with specific diets (eg: strict low-FODMAP). 3. Participation in another clinical trial within the past 4 weeks 4. Subject with known or suspected allergy to any component of the study product(s).
• \. Individuals receiving treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits.
• \. Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (Examples are members of a group with a hierarchical structure linked to the Investigator or to the Sponsor, such as students, subordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor).
• \. Individuals with antibiotics or proton pump inhibitor (e.g. omeprazole, lansoprazole and esomeprazole, pantoprazole, Rabeprazole) use within the previous 2 months 8. Individuals with current use of medication with potential central nervous system effects as judged by the investigator.
• \. Individuals with previous digestive surgery (except for appendectomy and cholecystectomy performed more than 2 years ago).
• \. Athletes as defined as performing daily strenuous daily exercise for more than 1.5 hours at a time.
• \. Oral disease that may impact on breath sampling e.g. gingivitis, halitosis, oral thrush, candidiasis.
• \. Individuals starting or routinely taking drugs (occasional use is acceptable) that might modify gastrointestinal function such as:
• Prokinetic agents e.g. metoclopramide (Reglan), tegaserod (Zelnorm), domperidone (Motilium),
• Anti-emetics agents
• Corticosteroids
• Narcotic analgesic agents e.g. methadone, fentanyl
• Anticholinergic agents for irritable bowel syndrome
• Medications for constipation e.g. enemas, cathartics, polyethylene glycol solutions, and lactulose.

Sponsors & Collaborators

• King's College London: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

Study Officials

• Kevin Whelan, PhD

  King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-over study

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: March 17, 2021
• Study Start: April 19, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)