GOS to Reduce Symptom Severity in IBS

NCT05157061 | Completed DMC

• 1 other identifier: EGIS-01
• Study Type: interventional
• Target: 153
• Locations: 3 countries
• Sites: 9

Brief Summary

IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. The chronic and bothersome nature of IBS symptoms negatively affects the quality of life of many patients. Because there are currently limited medical treatment options for IBS, it is important to study new treatments. IBS can (in part) be caused by an 'imbalance' of the bacteria residing in the intestinal tract. For instance, there may be a lower proportion of specific bacteria that are generally considered beneficial for a persons health. The consumption of non-digestible food ingredients, such as GOS, may stimulate the growth of these beneficial bacteria. GOS is a type of 'prebiotic', which is known to support health and wellbeing of consumers. By restoring the bacterial balance of the intestinal tract, the symptoms of IBS may be reduced after consumption of GOS. The health effects of the study product (a specific GOS) used in current study was previously investigated in a small group of patients with IBS. Use of the study product indicated a reduction in the patients' symptoms, improvement in the patients' quality of life, and changes in patients' gut bacteria. It is therefore hypothesized that GOS / a specific GOS may reduce the symptom severity of patients with IBS. This study further evaluates how GOS may improve symptoms of IBS.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome - Constipation; Irritable Bowel Syndrome - Diarrhoea; Irritable Bowel Syndrome - Mixed

Keywords

Irritable Bowel Syndrome; Diarrhoea; Constipation; Galacto-oligosaccharides (GOS); Symptom severity; Prebiotic; Supplement; Rome IV Criteria

Outcome Measures

Primary Outcomes (1)

• IBS symptom Severity

  The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores. The IBS System Severity Scores Scale consists of 5 questions each with scales ranging from 0 to 100, divided into steps of 10, whereby a score of 0 reflects the best outcome, and a score of 100 reflects the worst outcome.

  Baseline to end of the study (Day 56).

Secondary Outcomes (9)

• Abdominal pain

  During the intervention period (8 weeks)

• Bloating.

  During the intervention period (8 weeks)

• Global IBS improvement

  During the intervention period (8 weeks)

• Stool consistency

  During the intervention period (8 weeks)

• Defecation frequency

  During the intervention period (8 weeks)

Other Outcomes (5)

• Immune function

  At the end of the study (Day 56).

• Gut microbiome composition

  At the end of the study (Day 56).

• Blood metabolites

  At the end of the study (Day 56).

Study Arms (2)

GOS arm

EXPERIMENTAL

A single daily dose of a food supplement containing GOS for 8 weeks

Dietary Supplement: Galacto-oligosaccharides (GOS)

Placebo arm

PLACEBO COMPARATOR

A single daily dose of maltodextrin, matching in taste, smell, appearance, and solubility, but without active ingredients (i.e. GOS), for 8 weeks

Dietary Supplement: Maltodextrine

Interventions

Galacto-oligosaccharides (GOS) DIETARY_SUPPLEMENT

An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a prebiotic supplement is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.

Also known as: Prebiotic

GOS arm

Maltodextrine DIETARY_SUPPLEMENT

An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a placebo is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.

Also known as: Placebo

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with IBS by a medically trained person/Health Care Professional (HCP).
• IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary or secondary 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.

You may not qualify if:

• Unclassifiable IBS (IBS-U) as determined by Investigator
• Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
• 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 to study entry (i.e. treatment should be stable for at least 3 months prior to study entry).
• 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.
• 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.
• Galactosemia (galactose metabolism disorder)
• 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).
• 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.
• 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
• 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

Sponsors & Collaborators

• Clasado: lead
• CR2O B.V.: collaborator

Study Sites (9)

University Hospital Leuven location Gasthuisberg

Leuven, 3000, Belgium

Location

Jeroen Bosch Ziekenhuis, Gastroenterology department

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

Location

Medisch Centrum Leeuwarden (MCL)

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location

Ziekenhuis Gelderse Vallei, Afdeling Maag-Darm-Leverziekten

Ede, 6716 RP, Netherlands

Location

Leeds Teaching Hospital NHS Trust in association with the University of Leeds

Leeds, North Yorkshire, LS9 7TF, United Kingdom

Location

County Durham &Darlington NHS Foundation trust, University Hospital of North Durham

Durham, DH1 5TW, United Kingdom

Location

Barts Health NHS Trust, Wingate Clinical Trials Facility

London, E1 2AJ, United Kingdom

Location

Manchester University NHS Foundation Trust, Wythenshawe Hospital, Neurogastroenterology Unit

Manchester, M23 9LT, United Kingdom

Location

NIHR National Patient Recruitment Centre Newcastle

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Constipation

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Lucien F. Harthoorn, PhD.

  Clasado Research Services Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study team and DMC are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: October 26, 2021
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); BE (1); NL (3)