---
title: The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
nct_id: NCT03829358
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: Fakultas Kedokteran Universitas Indonesia
study_type: INTERVENTIONAL
primary_condition: Constipation - Functional
countries: Indonesia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03829358.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03829358"
ct_last_update_post_date: 2019-02-05
last_seen_at: "2026-05-12T07:32:00.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation

**Official Title:** The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial

**NCT ID:** [NCT03829358](https://clinicaltrials.gov/study/NCT03829358)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 76
- **Lead Sponsor:** Fakultas Kedokteran Universitas Indonesia
- **Collaborators:** United States Agency for International Development (USAID)
- **Conditions:** Constipation - Functional
- **Start Date:** 2018-02-24
- **Completion Date:** 2018-07-21
- **CT.gov Last Update:** 2019-02-05

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Probiotic** (EXPERIMENTAL) — Lactobacillus plantarum IS-10506
- **Placebo** (PLACEBO_COMPARATOR) — Placebo

## Interventions

- **Lactobacillus plantarum IS-10506** (DRUG) — Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
- **Placebo** (DRUG) — Fermented milk containing placebo to be consumed once daily for three weeks.

## Primary Outcomes

- **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

## Locations (1)

- Puskesmas Petamburan, Jakarta, DKI Jakarta, Indonesia

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.puskesmas petamburan|jakarta|dki jakarta|indonesia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03829358.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03829358*  
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