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Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885973
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Constipation - Functional Drug: Lactobacillus plantarum Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation: Molecular Profile of Fecal Microbiome With NGS Method
Actual Study Start Date : July 28, 2018
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Lactobacillus plantarum
1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10^8 CFU will be given daily for three weeks.
Drug: Lactobacillus plantarum
Fermented milk containing probiotic Lactobacillus plantarum for three weeks

Placebo Comparator: Placebo
1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks.
Drug: Placebo
Fermented milk containing placebo for three weeks




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885973


Locations
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Indonesia
Puskesmas Petamburan
Jakarta, DKI Jakarta, Indonesia, 11440
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Pratiwi D Kusumo Fakultas Kedokteran Universitas Indonesia
  Study Documents (Full-Text)

Documents provided by Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia:
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Responsible Party: Murdani Abdullah, Clinical Professor, Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03885973    
Other Study ID Numbers: 18-01-0060
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia:
SCFA
Probiotic
Lactobacillus plantarum
Functional constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive