Skip to main content
OpenTrials
Completed

NCT Number: NCT02254629

The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients

the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the presence of Rome III criteria for IBS ;
  • Patients scheduled for colonoscopy examination or having negative screening examinations
  • Aged between 18 and 65 years old

Exclusion criteria

  • Antibiotic, probiotic or laxative usage within 4 weeks.
  • organic gastrointestinal diseases
  • Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
  • pregnancy or lactation.
  • previous major or complicated abdominal surgery.
  • severe endometriosis and dementia

Treatment and study plan

Probiotic Clostridium Butyricum

Drug

probiotic:2 tablets/ times, 3 times / day for 2 weeks

Other names: Clostridium Butyricum Tablets

Laxative Polyethylene Glycol

Drug

laxative：2000 ml.

Other names: Polyethylene Glycol Electrolytes Powder.

Primary outcomes

  1. Subject's Global Assessment of Relief

    Time frame: 8 months

    The SGA (subjective global assessment) of Relief was assessed by answering the following question: "Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?" The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.

Secondary outcomes

  1. The changes of symptom scores

    Time frame: 8 months

    The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.

  2. IBS patients'quality of life

    Time frame: 8 months

    Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship.

  3. Composition of Microorganisms in stool

    Time frame: 8 months

    Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 2, 2014
Registry last updated
Aug 31, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.