Primary Objective:To establish the efficacy of treatment with Bimuno on total IBS symptom severity in patients with IBSSecondary Objectives:To assess efficacy of treatment with Bimuno on (I) abdominal pain, (II) bloating, (III) global IBS…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in total IBS symptom severity between treatment arms as measured
by mean composite IBS Symptom Severity Scale scores at the end of the study
(Day 56)
Secondary outcome
I. The difference in abdominal pain between treatment groups as measured by the
mean abdominal pain symptom scores during the intervention period.
II. The difference in bloating between treatment groups as measured by the mean
bloating symptom scores during the intervention period.
III. The difference in global IBS improvement between treatment arms as
measured by the mean IBS Global Improvement Scale scores during the
intervention period.
IV. The difference in stool consistency between treatment arms, per subtype of
IBS**, as measured by the median Bristol Stool Form Scale stool type during the
intervention period.
V. The difference in defecation frequency between treatment arms, per subtype
of IBS**, as measured by the mean patient-reported defecation frequency during
the intervention period.
VI. The difference in quality of life between treatment arms as measured by the
mean composite IBS Quality of Life scores at the end of the study (Day 56).
VII. The difference in anxiety and depression between treatment arms, evaluated
separately using the mean IBS Hospital Anxiety and Depression Scale scores at
the end of the study (Day 56).
VIII. Nature, incidence, frequency, severity of adverse events/serious adverse
events and relationship to the study intervention.
IX. Compare the need and usage of rescue medication (anti-diarrheal medication
or laxatives) between the 2 treatment arms during the treatment period.
Background summary
Irritable bowel syndrome (IBS) is a highly prevalent and multifaceted
functional bowel disorder characterized by recurrent abdominal pain associated
with defecation or a change in bowel habits in the absence of detectable
structural and biochemical abnormalities (Rome IV Criteria). Disordered bowel
habits are typically present, such as constipation, diarrhoea or a mix of
constipation and diarrhoea, as are symptoms of abdominal bloating/distension.
The chronic and bothersome nature of IBS symptoms negatively affects patient
quality of life and introduces a substantial economic burden on patients and
the healthcare system. The gut microbiota composition and function may play a
pivotal role in the pathogenesis of IBS, as a reduction in endogenous
bifidobacteria, lactobacilli, and Faecalibacterium prausnitzii concentrations,
as well as small bowel bacterial overgrowth have been reported in IBS patients,
thereby introducing the gut microbiota as a potential target for treatment and
symptom relief. Intervention with non-digestible food ingredients, such as
galacto-oligosaccharides (GOS), may form a suitable intervention strategy, as
these *prebiotics* are known to modulate the gastrointestinal (GI) microbiota
and support health and wellbeing of the host. The safety and efficacy of GOS
has previously been evaluated in patients with IBS, which demonstrated that GOS
may reduce IBS symptom severity, improve quality of life, improve stool
consistency and defecation frequency and alter gut microbiota composition, in a
safe manner. As there are currently limited suitable medical treatments for
IBS, this study will evaluate the efficacy of Bimuno, a dietary supplement with
GOS, in reducing symptom severity of patients with IBS.
Study objective
Primary Objective:
To establish the efficacy of treatment with Bimuno on total IBS symptom
severity in patients with IBS
Secondary Objectives:
To assess efficacy of treatment with Bimuno on (I) abdominal pain, (II)
bloating, (III) global IBS improvement, (IV) stool consistency, (V) defecation
frequency, (VI) quality of life, (VII) anxiety and depression, (VIII), safety
of treatment with Bimuno, as well as the use of (IX) rescue medication, in
patients with IBS.
Exploratory Objectives:
To assess the effect of treatment with Bimuno on (A) immune function, (B) gut
microbiome composition, (C) blood metabolites, (D) the correlation between
blood metabolites and gut microbiome, and (E) the correlation between gut
microbiome and total IBS symptom severity.
Study design
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter,
8-week intervention study, preceded by a 2-week run-in period, to assess the
efficacy of Bimuno on symptom severity in adult patients with IBS.
Intervention
All patients in this study will complete a 2-week run-in period without
intervention and will then be matched 1:1 to receive 8 weeks of intervention
with either Bimuno or placebo (double-blind):
- Active treatment: A single daily dose of 1.8 grams of Bimuno, containing
1.37g of GOS, provided as soluble powder.
- Placebo: A single daily dose of 1.8 grams maltodextrin, matching in taste,
smell, appearance, and solubility, but without active ingredients (i.e. GOS).
Study burden and risks
The burden and risks of participating in the present study are low. The study
procedures form little risk for patients but may burden them. Blood and faeces
samples will be collected at 2 timepoints. Quantitative and qualitative data
collection does not burden patients in any other way than time spent. There
will be no costs for patients for treatment and sample collection and patients
will be reimbursed for associated travel expenses. Potential benefits of
consumption of Bimuno include reduced IBS symptom severity, improved QoL,
improved stool quality and defecation frequency, and reduced anxiety.
The consumption of both study products is considered safe and without risks.
Bimuno is marketed as a food supplement since 2007, has Generally Recognized As
Safe (GRAS) status for use in adults (GRN000484, FDA, 2013) and infants
(GRN000495, FDA, 2013) and has a long history of safe use. Recent safety
studies have concluded that the consumption of prebiotics, including GOS, is
well-tolerated and safe (Davani-Davari et al., 2019; Al-Sheraji et al., 2013).
Moreover, previous clinical studies with Bimuno in IBS patients were not
associated with any health risks (Wilson et al., 2020; Silk et al., 2009).
However, adverse events related to consumption of GOS may include minor GIT
complaints, such as stomach sensitivity, flatulence, rumbling, diarrhoea, and
nausea. No health risks are associated with the consumption of the other
ingredients in Bimuno, i.e. glucose, galactose, lactose. Furthermore, no health
risks are associated with the ingredients in placebo (maltodextrin).
Thames Valley Science Park, The Gateway, Collegiate Square 1
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GB
Thames Valley Science Park, The Gateway, Collegiate Square 1
Shinfield, Reading RG2 9LH
GB
Listed location countries
Age
Inclusion criteria
1. Patients who have been diagnosed with IBS by a medically trained
person/Health Care Professional (HCP).
2. IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary
or secondary care clinician, including a gastroenterologist, at study entry
3. An IBS Symptom Severity Scale score of >=125 points at baseline (V1)
4. Male or female between 18 and 64 years of age (age ranges included)
5. Possession of a smartphone
6. Willing and eligible to provide consent and comply with protocol and product
intake.
Exclusion criteria
1. Unclassifiable IBS (IBS-U) as determined by Investigator
2. Use of products marketed as prebiotics, probiotics or synbiotics within 4
weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion
criterion.
3. Systemic antibiotic or antimycotic treatment within 4 weeks prior to study
entry
4. Use of laxatives or antidiarrheal medication within 1 week prior to study
entry
5. An unstable antidepressant/antipsychotic treatment regimen within 3 months
prior to study entry (i.e. treatment should be stable for at least 3 months
prior to study entry).
6. Confirmed lactose intolerance, defined as patients who report response to
dietary elimination of lactose/dairy products. Confirmation is patient-reported
and not done within the scope of this study.
7. Confirmed food allergy, with reported confirmation based on OFC, IgE, or
skin prick test. Confirmation is patient-reported and not done within the scope
of this study.
8. Galactosemia (galactose metabolism disorder)
9. Following diets likely to affect study outcomes, including:
o low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric
restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein,
sugar-free, single-food, juicing/any day of juicing, any other restriction diet
(e.g. very low calory), or vegan diets (GOS is derived from cow*s milk).
10. Severe illness(es) or medical condition(s), including gastrointestinal
pathologies:
o GI ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel
resection, , bariatric surgery, acute or chronic diarrhoea secondary to
confirmed infectious gastroenteritis, or enteral or parenteral nutrition.
11. Subjects suffering from auto-immune disorders (e.g. Rheumatoid Arthritis,
Systemic lupus erythematosus, Multiple Sclerosis, Graves* Disease) that require
treatment with an immune modulator treatment or anti-inflammatory medication
12. Surgical operations to the mouth or gastrointestinal tract within 4 weeks
prior to study entry, or planned during the study
o Appendectomy within 6 months prior to study entry
13. Recent unintended weight loss:
o >5% of total body weight within 6 months prior to study entry
14. Excessive alcohol consumption (>14 units per week) and/or drug abuse
15. Pregnancy and lactation, or plan to become pregnant during the study period
16. Participation in other studies involving investigational or marketed
products concomitantly or within 3 months prior to study entry
17. Changes in diet, supplement or medication use likely to affect study
outcomes (i.e. medication that influences GI function) within 4 weeks prior to
study entry or planned during the study (at the discretion of the
Investigator). For example, the following medications will influence GI
function and changes must be avoided: opioids, prokinetics (domperidone,
metoclopramide, prucalopride), antispasmodics (peppermint oil, buscopan), and
acid suppressants (PPI, H2 blockers). Of note: the intake of fibres (e.g.
psyllium husk) may be used provided that the participant has been using this as
a supplement for more than 4 weeks prior to study participation and intake does
not change during the course of participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76170.056.21 |
| Other | NL9317 |