ClinicalTrials.Veeva

Menu

Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

U

University of Indonesia (UI)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Constipation - Functional

Treatments

Drug: Lactobacillus plantarum
Drug: Placebo

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03885973
18-01-0060

Details and patient eligibility

About

In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days

Enrollment

76 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
  • Having the symptoms and signs of functional constipation refer to ROME IV
  • Able to communicate well
  • Able to consume 1 bottle of fermented milk each day for three weeks
  • Not using antibiotic no later than one week before supplementation

Exclusion criteria

  • Diagnosed with functional bowel disorder
  • Using anesthesia at least 4 weeks before treatment
  • Having a serious pathological disorder (carcinoma)
  • During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
  • Having severe heart disease
  • Taking chronic medications such as antidepressants or analgesics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

76 participants in 2 patient groups, including a placebo group

Lactobacillus plantarum
Experimental group
Description:
1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10\^8 CFU will be given daily for three weeks.
Treatment:
Drug: Lactobacillus plantarum
Placebo
Placebo Comparator group
Description:
1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems