Functional Bloating (Disorder)Pre-FIBReNCT04802798
Pre-FIBRe Study: Predeterminants of Fibre Induced Bloating Response.
A study testing Fibre 1 and Fibre 2 in people with Functional Bloating (Disorder), run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Bloating (Disorder)
- What is being tested?
- Fibre 1 and Fibre 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2021to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. Excessive habitual intake of fructans, galacto-oligosaccharides, polyols or fructose, as defined by clinician as the sole cause of symptoms.
- 2. 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).
- 5. Individuals receiving treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits.
- 6. 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).
- 7. 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.
- 9. Individuals with previous digestive surgery (except for appendectomy and cholecystectomy performed more than 2 years ago).
Show all 22Show fewer
- 10. Athletes as defined as performing daily strenuous daily exercise for more than 1.5 hours at a time.
- 11. Oral disease that may impact on breath sampling e.g. gingivitis, halitosis, oral thrush, candidiasis.
- 12. 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.
- 5HT3 antagonists e.g. alosetron and ondansetron.
- Anti-diarrheal agents e.g. Imodium (loperamide)
- Opiate agents used to treat diarrhoea.
- NSAIDs e.g. ibuprofen
- Histamine2 blockers e.g. cimetidine (Tagamet), famotidine (Pepcid), and ranitidine hydrochloride (Zantac), nizatidine (Axid)
- Antacids e.g. Gaviscon, Maalox, Tums, or any that contain magnesium or aluminium
- Supplements used to treat bloating: activated charcoal, alpha galactosidase 13. Women who report they are pregnant/lactating/planning pregnancy 14. Recent/ongoing consumption of probiotics/prebiotic supplements (past 4 weeks) 15. Anticipated changes to consumption of naturally probiotic/prebiotic containing foods e.g. yogurt with live cultures or cereals with chicory etc, in the next 2 months 16. Anticipated changes to smoking habits in the next 2 months 17. Ongoing abuse of alcohol (>40 units per week)/non-prescription drugs/other medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbial Profiles in Fermentable Carbohydrate Induced Bloating: an Exploratory Double-blind, Randomized Cross-over, Trial
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.
Read the detailed description
The investigators have 4 hypotheses linked to 4 research questions that will be answered by this research:
Hypothesis 1: participants with self-reported functional bloating in response to either fibre-1 or fibre-2, but not both, will respond symptomatically to fibre-1 or fibre-2, defined as 'fibre-1 responders' and 'fibre-2 responders'.
Hypothesis 2: participants with functional bloating who are 'fibre-1 responders' will be distinguishable from 'fibre-1 non-responders', and 'fibre-2 responders' will be distinguishable from 'fibre-2 non-responders', based upon faecal microbial profiles identified using faecal metagenomics, transcriptomics and metabolites at baseline and following the fibre-1 and fibre-2 interventions.
Hypothesis 3: the microbiota, clinical and nutritional profiles of participants with functional bloating will be interrelated and these relationships will be distinguishable between 'fibre-1 responders', 'fibre-1 non-responders', and 'fibre-2 responders' and 'fibre-2 non-responders'.
Hypothesis 4: participants with visceral hypersensitivity will have different faecal microbiota and will be more likely to be a 'fibre-1 responders' or 'fibre-2 responders' than 'non-responders'.
Participants in the trial will take three different dietary substances, each at a dose of 8 grams per day (split into two serves of 4 gram doses) for 7-days in a double-blinded randomised order with a 3-week washout period in between each intervention. The products are provided in powdered format and will be mixed with water before drinking. The products being provided are glucose, and fibre-1 or fibre-2 (all extracts of commonly consumed food products).
- Conditions
- Functional Bloating (Disorder)
- Being tested
- Fibre 1, Fibre 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre 1Dietary supplement
Food derived fibre presented as a white powder
Fibre 2Dietary supplement
Food derived fibre presented as a white powder
PlaceboDietary supplement
Simple sugar, presented as a white powder
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Fibre 1; Dietary Supplement: Fibre 2; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 63
Secondary outcomes (12)
Secondary response measure: Adequate relief of bloating symptoms assessed by the Global Symptom Questionnaire (GSQ) (Secondary clinical response)
As this is an exploratory study to determine the underlying mechanisms of bloating the investigators have identified a primary and secondary clinical 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 secondary responder definition is: reporting not having adequate relief of bloating symptoms on at least two of the final three days of the fibre-1 or fibre-2 challenge, measured using the dichotomous Global Symptom Questionnaire (GSQ). The secondary responder definition of response will also be measured at the end of the placebo period.
Measured: 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)
The IGQ is a multi-choice questionnaire that assesses 17 symptoms associated with abdominal gas production using a Likert scale (0-10).
Measured: 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)
The GSRS is a 4-point Likert scale (0-3, absent-severe) assessing 16 gastrointestinal symptoms.
Measured: 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 is a visual aid to help track stool form, stool form is ranked from type 1-7 and each stool passed will be recorded according to this scale.
Measured: 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 using a visual guide for where to measure and a metric measuring tape.
Measured: 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).
Clinical profile: Visceral hypersensitivity - rectal barostat
Visceral hypersensitivity will be measured using a rectal barostat to measure rectal pressure tolerance (mm Hg) and provide a dichotomous hypersensitivity outcome (yes/no).
Measured: Visceral hypersensitivity will be measured during the first washout period (between day 7 and day 28)
Nutrition profile: Energy and nutrient intake
Energy and nutrient analysis will be recorded in prospective 7-day diaries and assessed using computerised software (Nutritics) based on food composition data from standard United Kingdom (McCance and Widdowson 2016) food composition tables);
Measured: Energy and nutrient intake 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).
Nutrition profile: Fermentable oligo-, di-, mono- saccharide and polyol (FODMAP) intake
Diet diaries will be analysed for FODMAP intake using the Monash University FODMAP calculator.
Measured: Dietary intake 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).
Microbiome profile: Faecal transcriptomics from stool sample (microbiota activity) (metatranscriptomics profiling)
Measured: Days 21, 28, 35, 56, and 63
Microbiome profile: Faecal Volatile Organic Compounds (VOC) (gas-chromatography mass-spectrometry) from stool sample
Measured: Days 21, 28, 35, 56, and 63
Microbiome profile: Faecal Short-Chain Fatty Acids (SCFA) (gas-liquid chromatography) from stool sample
Measured: Days 21, 28, 35, 56, and 63
Microbiome profile: Fermentation (direct breath hydrogen and methane tests) using Gastrogenius breath-gas analyser
Measured: Days 21, 28, 35, 56, and 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start19 Apr 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Bloating (Disorder)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia Research
- Responsible party
- Sponsor
- Investigators
- Kevin Whelan, PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802798
- Sponsor's protocol ID
- HR-19/20-18704
- Acronym
- Pre-FIBRe
- Status last verified
- Jan 2022
- First submitted
- 5 Feb 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Profiles in Fermentable Carbohydrate Induced Bloating: an Exploratory Double-blind, Randomized Cross-over, Trial
- ClinicalTrials.gov ID
- NCT04802798
- Acronym / sponsor ID
- Pre-FIBRe / HR-19/20-18704
- Conditions
- Functional Bloating (Disorder)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Danone Nutricia Research
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators have 4 hypotheses linked to 4 research questions that will be answered by this research:
Hypothesis 1: participants with self-reported functional bloating in response to either fibre-1 or fibre-2, but not both, will respond symptomatically to fibre-1 or fibre-2, defined as 'fibre-1 responders' and 'fibre-2 responders'.
Hypothesis 2: participants with functional bloating who are 'fibre-1 responders' will be distinguishable from 'fibre-1 non-responders', and 'fibre-2 responders' will be distinguishable from 'fibre-2 non-responders', based upon faecal microbial profiles identified using faecal metagenomics, transcriptomics and metabolites at baseline and following the fibre-1 and fibre-2 interventions.
Hypothesis 3: the microbiota, clinical and nutritional profiles of participants with functional bloating will be interrelated and these relationships will be distinguishable between 'fibre-1 responders', 'fibre-1 non-responders', and 'fibre-2 responders' and 'fibre-2 non-responders'.
Hypothesis 4: participants with visceral hypersensitivity will have different faecal microbiota and will be more likely to be a 'fibre-1 responders' or 'fibre-2 responders' than 'non-responders'.
Participants in the trial will take three different dietary substances, each at a dose of 8 grams per day (split into two serves of 4 gram doses) for 7-days in a double-blinded randomised order with a 3-week washout period in between each intervention. The products are provided in powdered format and will be mixed with water before drinking. The products being provided are glucose, and fibre-1 or fibre-2 (all extracts of commonly consumed food products).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- cross-over study
| Arm | Type | Receives |
|---|---|---|
| Placebo, Fibre 1, Fibre 2 | Experimental | Dietary Supplement: Fibre 1, Dietary Supplement: Fibre 2, Dietary Supplement: PlaceboAll 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). |
| Placebo, Fibre 2, Fibre 1 | Experimental | Dietary Supplement: Fibre 1, Dietary Supplement: Fibre 2, Dietary Supplement: PlaceboAll 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 1. Excessive habitual intake of fructans, galacto-oligosaccharides, polyols or fructose, as defined by clinician as the sole cause of symptoms.
- 2. 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).
- 5. Individuals receiving treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits.
- 6. 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).
- 7. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibre 1Food derived fibre presented as a white powder | Dietary supplement | Placebo, Fibre 1, Fibre 2, Placebo, Fibre 2, Fibre 1 |
| Fibre 2Food derived fibre presented as a white powder | Dietary supplement | Placebo, Fibre 1, Fibre 2, Placebo, Fibre 2, Fibre 1 |
| PlaceboSimple sugar, presented as a white powder | Dietary supplement | Placebo, Fibre 1, Fibre 2, Placebo, Fibre 2, Fibre 1 |
Primary outcome
Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of first intervention period (day 7)
Time frame: 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.
Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of second intervention period (day 35)
Time frame: 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.
Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of third intervention period (day 63)
Time frame: 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.
12 secondary outcomes
Secondary response measure: Adequate relief of bloating symptoms assessed by the Global Symptom Questionnaire (GSQ) (Secondary clinical response)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Clinical profile: Visceral hypersensitivity - rectal barostat
Time frame: Visceral hypersensitivity will be measured during the first washout period (between day 7 and day 28)
Nutrition profile: Energy and nutrient intake
Time frame: Energy and nutrient intake 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).
Nutrition profile: Fermentable oligo-, di-, mono- saccharide and polyol (FODMAP) intake
Time frame: Dietary intake 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).
Microbiome profile: Faecal transcriptomics from stool sample (microbiota activity) (metatranscriptomics profiling)
Time frame: Days 21, 28, 35, 56, and 63
Microbiome profile: Faecal Volatile Organic Compounds (VOC) (gas-chromatography mass-spectrometry) from stool sample
Time frame: Days 21, 28, 35, 56, and 63
Microbiome profile: Faecal Short-Chain Fatty Acids (SCFA) (gas-liquid chromatography) from stool sample
Time frame: Days 21, 28, 35, 56, and 63
Microbiome profile: Fermentation (direct breath hydrogen and methane tests) using Gastrogenius breath-gas analyser
Time frame: Days 21, 28, 35, 56, and 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Whelan, PhD study chair
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre 1 and Fibre 2 in people with Functional Bloating (Disorder), run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloating as measured by the Gastrointestinal Symptom Rating Scale (GSRS) (Primary clinical response): end of first intervention period (day 7) (time frame: Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.