---
title: "Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation"
nct_id: NCT04451096
overall_status: COMPLETED
phase: PHASE3
sponsor: National University of Malaysia
study_type: INTERVENTIONAL
primary_condition: Parkinson Disease
countries: Malaysia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04451096.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04451096"
ct_last_update_post_date: 2020-06-30
last_seen_at: "2026-05-12T06:59:26.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation

**Official Title:** Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled Study

**NCT ID:** [NCT04451096](https://clinicaltrials.gov/study/NCT04451096)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** National University of Malaysia
- **Conditions:** Parkinson Disease, Constipation
- **Start Date:** 2018-10-06
- **Completion Date:** 2019-02-28
- **CT.gov Last Update:** 2020-06-30

## Brief Summary

A double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics on constipation symptoms and whole gut transit time in patients with Parkinson's disease.PD patients with constipation were randomized to receive a multi-strain probiotic (Lactobacillus spp and Bifidobacterium spp at 30 X 109 CFU) with fructo-oligosaccaride (FOS) or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes include changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary and exploratory outcomes include whole gut transit time (WGTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS).

## Detailed Description

This was an eight-week double-blind, randomized placebo-controlled intervention study involving 55 idiopathic PD patients attending tertiary hospital. This study was conducted in accordance with good clinical practice as per Declaration of Helsinki and was approved by the institution's Research and Ethics Committee (FF-2018-387). Written informed consent was obtained from all particpants prior to enrollment.

Participants were included if they were aged 18 or older; were diagnosed with idiopathic PD in Hoehn and Yahr stages 1-4, and fulfilled the Rome III criteria for functional constipation which requires the presence of recurrent abdominal pain 3 days per month in the last 3 months, and symptom onset 6 months prior to diagnosis, with additional criteria below to be fulfilled, as adapted from Longstreth, et al12.

1. Must include two or more of the following:

   1. Straining during at least 25% of defecations
   2. Lumpy or hard stools in at least 25% of defecations
   3. Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations

   e. Manual maneuvers to facilitate at least 25% of defecations (e.g, digital evacuation, support of the pelvic floor) f. Fewer than 3 defecations per week
2. Loose stools are rarely present without the use of laxatives
3. There are insufficient criteria for IBS

Participants were excluded if they had: a MMSE score of ≤ 21/30; a positive stool occult blood screening; a diagnosis of secondary parkinsonism; previous history of small and large bowel disease; prior history of gastrointestinal tract surgery; use of probiotics or antibiotics two weeks prior to baseline visit; been on medications such as antidepressants or anticholinergics; history of lactose intolerance; concomitant diagnosis of hypothyroidism and diabetes mellitus.

All participants were assessed at baseline and at 8 weeks following intervention for all outcome assessments. At baseline, additional data on demographics (age, sex, educational level), duration of PD, dopaminergic medication, Hoehn \& Yahr Scoring during ON period, and the level of physical activity were recorded at baseline. A sedentary behaviour was defined as being physically active \< 4 hours /week.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age 18 or older; were diagnosed with idiopathic PD
* PD with Hoehn and Yahr stages 1-4,
* Fulfilled the Rome III criteria for functional constipation

Exclusion Criteria:

* MMSE score of ≤ 21/30
* Positive stool occult blood screening
* Diagnosis of secondary parkinsonism
* Previous history of small and large bowel disease
* History of gastrointestinal tract surgery
* Use of probiotics or antibiotics two weeks prior to baseline visit
* Been on medications such as antidepressants or anticholinergics
* History of lactose intolerance
* Concomitant diagnosis of hypothyroidism and diabetes mellitus.
```

## Arms

- **Probiotic with prebiotic** (ACTIVE_COMPARATOR) — Drug: Probiotic sachet containing granulated multiple strains of Lactobacillus and Bifidobacterium, granulated fermented milk, lactose, fructo-oligosaccharide (FOS) with orange flavouring.
- **Placebo** (PLACEBO_COMPARATOR) — Drug : Placebo sachet of granulated milk, lactose and orange flavouring, without FOS or microbial cells which appeared similar to the probiotics

## Interventions

- **Probiotics with prebiotic** (DIETARY_SUPPLEMENT) — Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
- **Placebo** (DIETARY_SUPPLEMENT) — Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks

## Primary Outcomes

- **constipation symptoms** _(time frame: 8 weeks)_ — The presence of constipation symptoms at baseline and at 8 weeks evaluated by

Garrigues Questionnaire (GQ).GQ is a 21-item self-reported screening questionnaire to detect the presence of constipation symptoms, using two different sets of four-point Likert scale responses.Although 12 items assess bowel habits, 9 items specifically assess constipation symptoms and were used in our evaluation: (i)Feeling of blockage in the anus;(ii) Need to press around anus/vagina to complete bowel movement; (iii) Spend \>10 minutes to pass stool;(iv) Straining during bowel movement;(v) Feeling of hard stool;(vi) Feeling of incomplete emptying sensation; (vii)Bowel opening frequency;(viii) Frequency of oral laxative use;(ix) Frequency of enema use

## Secondary Outcomes

- **Whole Gut Transit Time (WGTT) in hours** _(time frame: 8 weeks)_
- **Frequency of patients with constipation (Bowel motion < 3 per week) in percentage** _(time frame: 8 weeks)_
- **Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 11** _(time frame: 8 weeks)_
- **Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 111** _(time frame: 8 weeks)_
- **Non motor symptom score** _(time frame: 8 weeks)_
- **Parkinsons Disease Quality of Life -39 Summary Index (PDQ39SI)** _(time frame: 8 weeks)_
- **Weight in kilogram** _(time frame: 8 weeks)_
- **Height in metres** _(time frame: Baseline)_
- **Body Mass Index (kg/m2)** _(time frame: 8 weeks)_

## Locations (1)

- Hospital Canselor Tuanku Muhriz, UKM Medical Center, Kuala Lumpur, Malaysia

## Recent Field Changes (last 30 days)

- `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.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital canselor tuanku muhriz, ukm medical center|kuala lumpur||malaysia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04451096.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04451096*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*