---
title: Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
nct_id: NCT02207140
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: Gabriella C. van Zanten
study_type: INTERVENTIONAL
primary_condition: Elderly
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02207140.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02207140"
ct_last_update_post_date: 2016-06-21
last_seen_at: "2026-05-12T06:50:16.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly

**NCT ID:** [NCT02207140](https://clinicaltrials.gov/study/NCT02207140)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Gabriella C. van Zanten
- **Conditions:** Elderly, Probiotics, Clostridium Difficile, Gut Microbiota, Fecal Metabolome
- **Start Date:** 2014-10
- **Completion Date:** 2016-05
- **CT.gov Last Update:** 2016-06-21

## Brief Summary

The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.

## Eligibility

- **Minimum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy
* aged 75 years or more

Exclusion Criteria:

* Individuals with chronic bowel diseases
* Individuals with severe immunosuppression
* Individuals with dementia
* Individuals who are terminally ill
* If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
* Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
* Subjects with a history of substance abuse
* Subjects that, in the investigators opinion, are not expected to complete the study succesfully
```

## Arms

- **probiotic** (EXPERIMENTAL) — HOWARU Restore
- **placebo** (PLACEBO_COMPARATOR) — microcrystalline cellulose

## Interventions

- **HOWARU Restore** (DIETARY_SUPPLEMENT)

## Primary Outcomes

- **Fecal Clostridium difficile numbers** _(time frame: 24 weeks)_

## Secondary Outcomes

- **fecal microbial composition** _(time frame: 24 weeks)_

## Locations (1)

- Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Frederiksberg C, Denmark

## 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.department of food science, food microbiology, faculty of science, university of copenhagen|frederiksberg c||denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02207140.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02207140*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*