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CompletedNCT03308461Updated Oct 12, 2017

Fecal Microbiota Transplantation for Constipation

An interventional study of Fecal Microbiota suspension in Gut Microbiota and Constipation, sponsored by The Second Hospital of Nanjing Medical University. Completed at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
14 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Gut Microbiota
  • Constipation

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Keywords

  • difficult defecation
  • fecal microbiota transplantation
  • stool pattern
03

Who can participate

Ages eligible
14 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age between 14-80 years old;
  2. 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

Exclusion Criteria:

  1. difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
  2. with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
  3. pregnant or breast-feeding women;
  4. 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Fecal microbiota transplantation (FMT)

    Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.

    Drug: Fecal Microbiota suspension

Interventions

  • DrugFecal Microbiota suspension

    The prepared microbiota suspension was infused into mid-gut.

05

What researchers measure

Primary outcomes

  1. defecation frequency

    frequency of defecation per week

    Time frame: 12 weeks

  2. stool consistency

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

    Time frame: 12 weeks

06

Study locations

1 site
  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
07

References and documents

Publications

  • Vandeputte D, Falony G, Vieira-Silva S, Tito RY, Joossens M, Raes J. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016 Jan;65(1):57-62. doi: 10.1136/gutjnl-2015-309618. Epub 2015 Jun 11. PubMed 26069274 ↗
  • Tigchelaar EF, Bonder MJ, Jankipersadsing SA, Fu J, Wijmenga C, Zhernakova A. Gut microbiota composition associated with stool consistency. Gut. 2016 Mar;65(3):540-2. doi: 10.1136/gutjnl-2015-310328. Epub 2015 Aug 14. No abstract available. PubMed 26276682 ↗
  • Duncan SH, Louis P, Flint HJ. Lactate-utilizing bacteria, isolated from human feces, that produce butyrate as a major fermentation product. Appl Environ Microbiol. 2004 Oct;70(10):5810-7. doi: 10.1128/AEM.70.10.5810-5817.2004. PubMed 15466518 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03308461
Lead sponsor
The Second Hospital of Nanjing Medical University
Responsible party
Faming Zhang (Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University) — Principal investigator
First posted
Oct 12, 2017
Start date
May 1, 2013
Primary completion
May 1, 2017
Completion
May 1, 2017
Last update
Oct 12, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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