---
title: Characteristics of Intestinal Microbiome Following Pancreatic Surgery
nct_id: NCT06319755
overall_status: RECRUITING
sponsor: Royal Prince Alfred Hospital, Sydney, Australia
study_type: OBSERVATIONAL
primary_condition: Pancreatic Cancer
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06319755.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06319755"
ct_last_update_post_date: 2025-07-24
last_seen_at: "2026-05-12T07:32:32.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Characteristics of Intestinal Microbiome Following Pancreatic Surgery

**Official Title:** Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study

**NCT ID:** [NCT06319755](https://clinicaltrials.gov/study/NCT06319755)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Royal Prince Alfred Hospital, Sydney, Australia
- **Conditions:** Pancreatic Cancer, Microbiota, Pancreatoduodenectomy
- **Start Date:** 2024-08-01
- **Completion Date:** 2025-08
- **CT.gov Last Update:** 2025-07-24

## Brief Summary

The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.

The primary objectives of the study are:

1. To explore and describe any differences in the gut microbiota especially Shannon diversity index
2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.

Participants will be asked to complete the following:

* Three-day food, bowel and medication diary (see Protocol appendix 5)
* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)
* Quality of life questionnaire (see Protocol appendix 7)
* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Adults (aged equal to or greater than 18 years) having had pancreatoduodenectomy (Whipple's) surgery between April 2018 - December 2023 for curative intent and received post-operative clinical management at Royal Prince Alfred Hospital, (post-surgical participants), and
* Healthy adults matched by age, sex, body mass index and smoking status

Exclusion Criteria:

* Aged less than 18 years
* Are unable to complete the questionnaires or testing due to language or cognitive limitations
* Have active or recurring pancreatic cancer, or where the surgery was for non-curative intent
* Have other gastrointestinal conditions that could affect gut symptoms or microbiome such as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or are currently pregnant or breastfeeding
* Are currently taking medications or diet that can affect gut symptoms or microbiome
```

## Arms

- **Post-surgical patients** — Adults having had pancreatoduodenectomy (Whipple's) surgery for curative intent.
- **Matched controls** — Participants matched to each post-surgical participant by age, sex, body mass index (BMI), smoking status.

## Primary Outcomes

- **Comparison of microbiota profile between post-surgical participants and healthy controls.** _(time frame: During data collection, 3 days)_ — Stool samples will be analysed to compare the Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) between participant groups.

## Secondary Outcomes

- **Compliance with 3-day food dairies** _(time frame: From enrollment to the collection of data from participants, 3 days)_
- **Pre-paid return rates** _(time frame: From enrollment to the collection of data from participants, 3 days)_
- **Ease of matching** _(time frame: Enrollment period, up to 12 months)_
- **Shannon diversity index** _(time frame: During data collection period, 3 days)_
- **Gastrointestinal symptoms** _(time frame: During data collection period, 3 days)_
- **Protein:fibre ratio of diet** _(time frame: During data collection period, 3 days)_

## Locations (1)

- Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia — _RECRUITING_

## 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.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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of nutrition and dietetics, royal prince alfred hospital|camperdown|new south wales|australia` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06319755*  
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