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OpenTrials
Completed

NCT Number: NCT02108119

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PreCare Trial & Recruitment

Beek, 6191, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

Control placebo

Dietary Supplement

Primary outcomes

  1. Abdominal pain

    Time frame: 28 days

    0-10 numeric rating scale (NRS)

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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