---
title: Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
nct_id: NCT01804959
overall_status: UNKNOWN
phase: PHASE2
sponsor: Singapore General Hospital
study_type: INTERVENTIONAL
primary_condition: Systemic Sclerosis
countries: Singapore
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01804959.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01804959"
ct_last_update_post_date: 2018-09-10
last_seen_at: "2026-05-12T06:58:12.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

**Official Title:** A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

**NCT ID:** [NCT01804959](https://clinicaltrials.gov/study/NCT01804959)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Singapore General Hospital
- **Conditions:** Systemic Sclerosis
- **Start Date:** 2013-05
- **Completion Date:** 2020-12
- **CT.gov Last Update:** 2018-09-10

## Brief Summary

SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire.

## Eligibility

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

```
Inclusion Criteria:

* SSc that fulfills the American College of Rheumatology (ACR, 1990) classification criteria or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis.
* SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases)
* SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10
* Stable doses of immunosuppressive treatment, corticosteroids, and GI medications for 30 days.

Exclusion Criteria:

* On anti-biotics or probiotics within the last 30 days
* Current serious infections requiring hospitalization
* Long-term indwelling catheter, including patients on total parenteral nutrition
* Females who are lactating or pregnant
```

## Arms

- **Active vs Placebo** (PLACEBO_COMPARATOR) — In phase I, subjects will be randomized into either the Vivomixx probiotics or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotics (4 sachets/ day or 1800 billion bacteria/day) or placebo (4 placebo sachets/day) for the first 60 days.
- **60 days of Active vs 120 days of Active** (ACTIVE_COMPARATOR) — In phase II, subjects from both arms in phase I will receive Vivomixx probiotics 4 sachets/ day for another 60 days. Comparison will be made between the arm receiving 60 days of Vivomixx probiotics vs 120 days of Vivomixx probiotics

## Interventions

- **Vivomixx probiotics** (DIETARY_SUPPLEMENT)

## Primary Outcomes

- **mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.** _(time frame: After 60 days of either placebo treatment or active drug treatment)_

## Secondary Outcomes

- **mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.** _(time frame: After 120 days of placebo treatment or active drug treatment)_

## Locations (1)

- Singapore General Hospital, Singapore, Singapore

## 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.singapore general hospital|singapore||singapore` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01804959.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01804959*  
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