The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
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|ClinicalTrials.gov Identifier: NCT03829358|
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Constipation - Functional||Drug: Lactobacillus plantarum IS-10506 Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
Fermented milk containing placebo to be consumed once daily for three weeks.
- 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
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
|Jakarta, DKI Jakarta, Indonesia, 11440|
|Principal Investigator:||Hasan Maulahela, MD||Fakultas Kedokteran Universitas Indonesia|