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NCT Number: NCT06319755

Characteristics of Intestinal Microbiome Following Pancreatic Surgery

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)

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Microbiota Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pancreatoduodenectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition and Dietetics, Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location status: Recruiting

Location contact

Dale Palmer

CONTACT

[email protected]

+610295158053

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Compliance with 3-day food dairies

    Time frame: From enrollment to the collection of data from participants, 3 days

    Compliance with 3-day food dairies (completion rate of food diaries)

  2. Pre-paid return rates

    Time frame: From enrollment to the collection of data from participants, 3 days

    Pre-paid return rates (proportion (number) of envelopes returned)

  3. Ease of matching

    Time frame: Enrollment period, up to 12 months

    Ease of matching (ability to match surgical patients to controls based on age, gender, body mass index, smoking status)

  4. Shannon diversity index

    Time frame: During data collection period, 3 days

    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)

  5. Gastrointestinal symptoms

    Time frame: During data collection period, 3 days

    Gastrointestinal symptoms (total number of bowel motions)

  6. Protein:fibre ratio of diet

    Time frame: During data collection period, 3 days

    Protein:fibre ratio of diet (average grams of protein consumed divided by grams of fibre consumed)

Study contacts

Contact information is provided by the study sponsor or research team.

Dale Palmer

CONTACT

[email protected]

61295158053

Sponsors and collaborators

Lead sponsor

Royal Prince Alfred Hospital, Sydney, Australia

Other

Registry information

Official study title

Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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