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

Probi AB

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Control placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02108119

PRO008

Details and patient eligibility

About

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

Enrollment: 197 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Treatment:

Dietary Supplement: Probiotics

Control placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Control placebo