Effects of Activia in IBS

NCT01252550 | Completed DMC

• 1 other identifier: NU341
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; GI; QOL; Pathophysiology; Gut microbiota; Danone; Activia; Probiotics

Outcome Measures

Primary Outcomes (1)

• IBS symptoms

  8 Weeks

Study Arms (2)

Activia®

ACTIVE COMPARATOR

Activia® (125g/pot)

Dietary Supplement: Activia® (125g/pot)

Acidified non-fermented dairy product

PLACEBO COMPARATOR

Acidified non-fermented dairy product (125g/pot)

Dietary Supplement: Acidified non-fermented dairy product

Interventions

Activia® (125g/pot) DIETARY_SUPPLEMENT

Activia® (125g/pot) - dairy product containing bacterial culture Acti Regularis®

Activia®

Acidified non-fermented dairy product DIETARY_SUPPLEMENT

Acidified non-fermented dairy product (125g/pot)

Acidified non-fermented dairy product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age: between 18 and 65 years old at baseline visit
• IBS according to the Rome III criteria
• Ability to understand and willingness to comply to the study procedures

You may not qualify if:

• Participation in another clinical study 1 month prior to screening visit and throughout the study
• Abnormal results on the screening laboratory tests clinically relevant for study participation
• Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
• Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
• Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
• Severe psychiatric disease
• Previous history of drug or alcohol abuse 6 months prior to screening
• Intolerance or allergy against milk products or gluten
• Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study
• Consumption of antibiotics 1 month prior to screening and throughout the study
• Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study
• Pregnant or lactating or wish to become pregnant during the period of the study

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (3)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, S413-45, Sweden

Location

Related Publications (6)

• Tap J, Storsrud S, Le Neve B, Cotillard A, Pons N, Dore J, Ohman L, Tornblom H, Derrien M, Simren M. Diet and gut microbiome interactions of relevance for symptoms in irritable bowel syndrome. Microbiome. 2021 Mar 26;9(1):74. doi: 10.1186/s40168-021-01018-9.

  PMID: 33771219 DERIVED

• Le Neve B, Derrien M, Tap J, Brazeilles R, Cools Portier S, Guyonnet D, Ohman L, Storsrud S, Tornblom H, Simren M. Fasting breath H2 and gut microbiota metabolic potential are associated with the response to a fermented milk product in irritable bowel syndrome. PLoS One. 2019 Apr 4;14(4):e0214273. doi: 10.1371/journal.pone.0214273. eCollection 2019.

  PMID: 30946757 DERIVED

• Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.

  PMID: 30838348 DERIVED

• Pohl D, Van Oudenhove L, Tornblom H, Le Neve B, Tack J, Simren M. Functional Dyspepsia and Severity of Psychologic Symptoms Associate With Postprandial Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1745-1753.e1. doi: 10.1016/j.cgh.2018.04.034. Epub 2018 Apr 24.

  PMID: 29702295 DERIVED

• Tap J, Derrien M, Tornblom H, Brazeilles R, Cools-Portier S, Dore J, Storsrud S, Le Neve B, Ohman L, Simren M. Identification of an Intestinal Microbiota Signature Associated With Severity of Irritable Bowel Syndrome. Gastroenterology. 2017 Jan;152(1):111-123.e8. doi: 10.1053/j.gastro.2016.09.049. Epub 2016 Oct 7.

  PMID: 27725146 DERIVED

• Le Neve B, Brazeilles R, Derrien M, Tap J, Guyonnet D, Ohman L, Tornblom H, Simren M. Lactulose Challenge Determines Visceral Sensitivity and Severity of Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2016 Feb;14(2):226-33.e1-3. doi: 10.1016/j.cgh.2015.09.039. Epub 2015 Oct 20.

  PMID: 26492847 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Magnus Simrén, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

SE (3)