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The efficacy and safety of fecal microbiota transplantation in the treatment of slow transit constipation

The efficacy and safety of fecal microbiota transplantation in the treatment of slow transit constipation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033227
Enrollment
Unknown
Registered
2020-05-25
Start date
2020-06-15
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Slow transit constipation

Interventions

Sponsors

Tianjin Union Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months; 2. Aged >= 18 years; 3. BMI: 18.5-25 kg/m2; 4. Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours); Normal anorectal manometry with no evidence of dyssynergia and confirmed ability to expel rectal balloon; 5. Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion criteria

Exclusion criteria: 1. Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders); 2. History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases); 3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section; 4. Previous proctological or perianal surgery; 5. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome; 6. Pregnant or breast-feeding women; 7. Infection with enteric pathogen; 8. Usage of probiotics, prebiotics and/or synbiotics within the last month; 9. Usage of antibiotics and/or PPIs within the last 3 months; 10. Smoking or alcohol addiction within the last 3 months; 11. Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease.

Design outcomes

Primary

MeasureTime frame
Defecation times per week;Stool form scale;Wexner constipation score;Gastrointestinal quality of life index;Geriatric depression scale;

Countries

China

Contacts

Public ContactLi Yuwei

Tianjin Union Medical Center

Liyuwei66@163.com+86 13920229000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026