Phase
Condition
Lactose Intolerance
Bowel Dysfunction
Constipation
Treatment
Galacto-oligosaccharides (GOS)
Maltodextrine
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who have been diagnosed with IBS by a medically trained person/Health CareProfessional (HCP).
IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary orsecondary care clinician, including a gastroenterologist, at study entry
An IBS Symptom Severity Scale score of ≥125 points at baseline
Male or female between 18 and 64 years of age (age ranges included)
Possession of a smartphone
Willing and eligible to provide consent and comply with protocol and product intake.
Exclusion
Exclusion Criteria:
Unclassifiable IBS (IBS-U) as determined by Investigator
Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeksprior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir). o Regular cheese or yogurt containing lactic acid bacteria are not an exclusioncriterion.
Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry
Use of laxatives or antidiarrheal medication within 1 week prior to study entry
An unstable antidepressant/antipsychotic treatment regimen within 3 months prior tostudy entry (i.e. treatment should be stable for at least 3 months prior to studyentry).
Confirmed lactose intolerance, defined as patients who report response to dietaryelimination of lactose/dairy products. Confirmation is patient-reported and not donewithin the scope of this study.
Confirmed food allergy, with reported confirmation based on OFC, IgE, or skin pricktest. Confirmation is patient-reported and not done within the scope of this study.
Galactosemia (galactose metabolism disorder)
Following diets likely to affect study outcomes, including: o low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloricrestriction, 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).
Severe illness(es) or medical condition(s), including gastrointestinal pathologies: o GI ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowelresection, , bariatric surgery, acute or chronic diarrhoea secondary to confirmedinfectious gastroenteritis, or enteral or parenteral nutrition.
Subjects suffering from auto-immune disorders (e.g. Rheumatoid Arthritis, Systemiclupus erythematosus, Multiple Sclerosis, Graves' Disease) that require treatmentwith an immune modulator treatment or anti-inflammatory medication
Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior tostudy entry, or planned during the study o Appendectomy within 6 months prior to study entry
Recent unintended weight loss: o >5% of total body weight within 6 months prior to study entry
Excessive alcohol consumption (>14 units per week) and/or drug abuse
Pregnancy and lactation, or plan to become pregnant during the study period
Participation in other studies involving investigational or marketed productsconcomitantly or within 3 months prior to study entry
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 orplanned during the study (at the discretion of the Investigator). For example, thefollowing 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: theintake of fibres (e.g. psyllium husk) may be used provided that the participant hasbeen using this as a supplement for more than 4 weeks prior to study participationand intake does not change during the course of participation.
Study Design
Study Description
Connect with a study center
University Hospital Leuven location Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Medisch Centrum Leeuwarden (MCL)
Leeuwarden, Friesland 8934AD
NetherlandsSite Not Available
Jeroen Bosch Ziekenhuis, Gastroenterology department
's-Hertogenbosch, Noord-Brabant 5223GZ
NetherlandsSite Not Available
Ziekenhuis Gelderse Vallei, Afdeling Maag-Darm-Leverziekten
Ede, 6716 RP
NetherlandsSite Not Available
Leeds Teaching Hospital NHS Trust in association with the University of Leeds
Leeds, North Yorkshire LS9 7TF
United KingdomSite Not Available
County Durham &Darlington NHS Foundation trust, University Hospital of North Durham
Durham, DH1 5TW
United KingdomActive - Recruiting
County Durham &Darlington NHS Foundation trust, University Hospital of North Durham
Durham, DH1 5TW
United KingdomSite Not Available
Barts Health NHS Trust, Wingate Clinical Trials Facility
London, E1 2AJ
United KingdomSite Not Available
Manchester University NHS Foundation Trust, Wythenshawe Hospital, Neurogastroenterology Unit
Manchester, M23 9LT
United KingdomSite Not Available
NIHR National Patient Recruitment Centre Newcastle
Newcastle Upon Tyne, NE4 6BE
United KingdomSite Not Available
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