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NCT Number: NCT03885973

Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

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

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Key information

Conditions

Constipation - Functional

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Puskesmas Petamburan

Jakarta, DKI Jakarta, 11440, Indonesia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lactobacillus plantarum

Drug

Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Placebo

Drug

Fermented milk containing placebo for three weeks

Primary outcomes

  1. Short Chain Fatty Acid (SCFA) titer

    Time frame: Three weeks after intervention

    Short Chain Fatty Acid (SCFA) titer that will be analyzed by Gas chromatography-mass spectrometry (GCMS) consists of three metabolites:

    • Butyrate will be shown in mM unit measure, higher value represents better outcome
    • Acetate will be shown in mM unit measure, higher value represents better outcome
    • Proprionate will be shown in mM unit measure, higher value represents better outcome

  2. Functional constipation symptom improvement (1)

    Time frame: Three weeks after intervention

    Functional constipation symptom improvement (1) will be measured by improvement of PAC Sym questionnaire score. PAC Sym (Patient Assessment of Constipation Symptoms) has a minimum score of 0, maximum score 48, lower value represents better outcome

  3. Functional constipation symptom improvement (2)

    Time frame: Three weeks after intervention

    Functional constipation symptom improvement (2) will be measured by improvement of PAC QoL questionnaire score. PAC QoL (Patient Assessment of Constipation Quality of Life) has a minimum score of -20, maximum score 92, lower value represents better outcome

  4. Molecular Profile of Fecal Microbiome

    Time frame: Three weeks after intervention

    Microbiome profile from faecal samples will be analyzed with NGS (Next Gen Sequencing) method. The result will be analyzed with MiSEq Reporter software (MSR) and will be presented in nM unit measure.

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study title

Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation: Molecular Profile of Fecal Microbiome With NGS Method

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2019
Registry last updated
Mar 25, 2019

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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