Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885973
• Other study ID #: 18-01-0060
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 28, 2018
• Est. completion date: August 22, 2018

Study information

• Verified date: March 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Drug:
• Lactobacillus plantarum
Fermented milk containing probiotic Lactobacillus plantarum for three weeks
• Placebo
Fermented milk containing placebo for three weeks

Locations

Country	Name	City	State
Indonesia	Puskesmas Petamburan	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Chain Fatty Acid (SCFA) titer	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	Three weeks after intervention
Primary	Functional constipation symptom improvement (1)	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	Three weeks after intervention
Primary	Functional constipation symptom improvement (2)	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	Three weeks after intervention
Primary	Molecular Profile of Fecal Microbiome	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.	Three weeks after intervention