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The Role of Probiotics in Improving Quality of Life 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: NCT03829358
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Murdani Abdullah, Fakultas Kedokteran Universitas Indonesia

Brief Summary:
This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.

Condition or disease Intervention/treatment Phase
Constipation - Functional Drug: Lactobacillus plantarum IS-10506 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: The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial
Actual Study Start Date : February 24, 2018
Actual Primary Completion Date : July 21, 2018
Actual Study Completion Date : July 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Probiotic
Lactobacillus plantarum IS-10506
Drug: Lactobacillus plantarum IS-10506
Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Fermented milk containing placebo to be consumed once daily for three weeks.




Primary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: Three weeks after intervention. ]

    Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.

    • Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome
    • Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome
    • Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome
    • Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome

    Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction

    • Total score, minimum score -20, maximum score 92, lower value represents better outcome




Information from the National Library of Medicine

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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): NCT03829358


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: Hasan Maulahela, MD 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: NCT03829358     History of Changes
Other Study ID Numbers: SMART CITY #AID-497-A-1600004
Sub Grant #IIE-00000078-UI-1 ( Other Grant/Funding Number: USAID/SHERA - SMART CITY )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 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:
Constipation
Quality of Life
Probiotic
PAC-QOL

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms