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

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108119
• Other study ID #: PRO008
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2014
• Last updated: June 15, 2017
• Start date: May 2, 2014
• Est. completion date: November 30, 2015

Study information

• Verified date: June 2017
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Probiotics

• Control placebo

Locations

Country	Name	City	State
Netherlands	PreCare Trial & Recruitment	Beek

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	0-10 numeric rating scale (NRS)	28 days