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Completed

NCT Number: NCT03308461

Fecal Microbiota Transplantation for Constipation

Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.

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Key information

Conditions

Gut Microbiota Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

About this study

Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 14-80 years old;
  • difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).

Exclusion criteria

  • difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
  • with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
  • pregnant or breast-feeding women;
  • infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.

Treatment and study plan

Fecal Microbiota suspension

Drug

The prepared microbiota suspension was infused into mid-gut.

Primary outcomes

  1. defecation frequency

    Time frame: 12 weeks

    frequency of defecation per week

  2. stool consistency

    Time frame: 12 weeks

    The category of stool consistency score based on the BSS (Bristol Stool Form Scale)

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

Fecal Microbiota Transplantation for Constipation With Difficult Defecation

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2017
Registry last updated
Oct 12, 2017

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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