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Fecal Microbiota Transplantation for Constipation

Fecal Microbiota Transplantation for Constipation With Difficult Defecation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03308461
Enrollment
22
Registered
2017-10-12
Start date
2013-05-01
Completion date
2017-05-01
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Gut Microbiota

Keywords

difficult defecation, fecal microbiota transplantation, stool pattern

Brief 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.

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.

Interventions

The prepared microbiota suspension was infused into mid-gut.

Sponsors

The Second Hospital of Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
defecation frequency12 weeksfrequency of defecation per week
stool consistency12 weeksThe category of stool consistency score based on the BSS (Bristol Stool Form Scale)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026