NCT02254629

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

August 28, 2014

Last Update Submit

August 30, 2016

Conditions

Irritable Bowel Syndrome

Keywords

Fecal microfloraIBSSequential treatmentProbioticLaxative

Outcome Measures

Primary Outcomes (1)

  • Subject's Global Assessment of Relief

    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.

    8 months

Secondary Outcomes (3)

  • The changes of symptom scores

    8 months

  • IBS patients'quality of life

    8 months

  • Composition of Microorganisms in stool

    8 months

Study Arms (3)

laxative-probiotic sequential

EXPERIMENTAL

laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy

Drug: Probiotic Clostridium ButyricumDrug: Laxative Polyethylene Glycol

probiotic

ACTIVE COMPARATOR

Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.

Drug: Probiotic Clostridium Butyricum

Laxative followed by Probiotic 2 weeks later

ACTIVE COMPARATOR

laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.

Drug: Probiotic Clostridium ButyricumDrug: Laxative Polyethylene Glycol

Interventions

Probiotic Clostridium ButyricumDRUG

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

Also known as: Clostridium Butyricum Tablets
Laxative followed by Probiotic 2 weeks laterlaxative-probiotic sequentialprobiotic
Laxative Polyethylene GlycolDRUG

laxative：2000 ml.

Also known as: Polyethylene Glycol Electrolytes Powder.
Laxative followed by Probiotic 2 weeks laterlaxative-probiotic sequential

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

  • Li M, Xu R, Li YQ. Sequential laxative-probiotic usage for treatment of irritable bowel syndrome: a novel method inspired by mathematical modelling of the microbiome. Sci Rep. 2020 Nov 9;10(1):19291. doi: 10.1038/s41598-020-75225-z.

    PMID: 33168839DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yanqing Li, MD.PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

  • Yanqing Li, MD.PhD.

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

August 28, 2014

First Posted

October 2, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

July 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

CN(1)