The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome

NCT02108119 | Completed Phase 2

• 1 other identifier: PRO008
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Abdominal pain

  0-10 numeric rating scale (NRS)

  28 days

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Dietary Supplement: Probiotics

Control placebo

PLACEBO COMPARATOR

Dietary Supplement: Control placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics

Control placebo DIETARY_SUPPLEMENT

Control placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Age ≥18 and ≤70 years at Visit 1
• IBS according to the Rome III criteria
• A score on abdominal pain NRS ≥3 and ≤6 at least two days a week measured the weeks before Visit 2 (baseline)
• IBS-SSS ≥75 and ≤300 at Visit 2 (baseline)
• Ability and willingness to understand and comply with the study procedures

You may not qualify if:

• Known intolerance or allergy to milk products (protein or lactose) or gluten
• History of alcohol or substance abuse six months prior to screening
• Known Hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2
• Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
• Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the Investigator
• Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator
• Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator
• Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator
• Severe psychiatric disease as judged by the Investigator
• Lack of suitability for participation in the study for any reason as judged by the Investigator
• Use of other probiotic products from Visit 1 and throughout the study.
• Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
• Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator.

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

PreCare Trial & Recruitment

Beek, 6191, Netherlands

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 9, 2014
• Study Start: May 2, 2014
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

NL (1)