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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02301221
Other study ID # RIGS-FMT-STC-2014
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received November 11, 2014
Last updated November 3, 2016
Start date March 2015
Est. completion date December 2016

Study information

Verified date November 2016
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.


Description:

Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old.

Recent evidence in the literature and collected in our laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs).

A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, we suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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;

- Age = 18 years;

- BMI: 18.5-25 kg/m2;

- 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;

- No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;

- Disease duration > 1 year;

- Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion Criteria:

- Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);

- History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;

- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;

- Previous proctological or perianal surgery;

- A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;

- Pregnant or breast-feeding women;

- Infection with enteric pathogen;

- Usage of probiotics, prebiotics and/or synbiotics within the last month;

- Usage of antibiotics and/or PPIs within the last 3 months;

- Smoking or alcohol addiction within the last 3 months;

- Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;

- Disease or therapy with drugs (i.e. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Drug:
Vancomycin and bowel lavage
An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.

Locations

Country Name City State
China Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients having on average three or more SCBMs/week Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at baseline and over the week interval 3-4, 9-12 and 21-24. 24 weeks No
Secondary Bowel habit assessments Patients kept daily diaries about times of bowel movements each day, stool consistency, degree of straining severity during defecation, and degree of sensation of incompleteness of evacuation. 24 weeks No
Secondary Constipation-related symptoms assessments Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and at week 4, 12, and 24. 24 weeks No
Secondary Quality-of-Life assessments Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at baseline and at week 4, 12, and 24. 24 weeks No
Secondary Colonic transit time measurements Colonic transit time (CTT) was measured at baseline and at week 4, 12 and 24 with the Metcalf method. 24 weeks No
Secondary Usage of laxatives or enemas as rescue medication If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax). If ineffective, enema were used. Patients kept daily diaries about the rescue medication when used. 24 weeks No
Secondary Adverse events Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders. 24 weeks Yes
See also
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Recruiting NCT05352074 - STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation N/A
Recruiting NCT02291354 - Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation Phase 2
Active, not recruiting NCT05718505 - Comparison of the Atmo Motility Gas Capsule System to the Reference Standard N/A
Recruiting NCT02676388 - Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation Phase 2
Recruiting NCT02984969 - Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients N/A