Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation

Slow Transit Constipation Clinical Trial

Official title:

Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676388
• Other study ID #: Freeze-dried FMT-STC
• Status: Recruiting
• Phase: Phase 2
• First received: February 3, 2016
• Last updated: March 13, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Jinling Hospital, China
• Contact: Jianfeng Gong, MD
• Phone: +86-25-80860036
• Email: jinlingh_gongjf[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT 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 the investigators' 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, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Slow Transit Constipation

Intervention

Procedure:
• Freeze-dried, Capsulized FMT

• Fresh FMT

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 week 4 and 12.	3 months	No
Secondary	Mean number of bowel movements per week	Patients kept daily diaries about times of bowel movements each day.	3 months	No
Secondary	Characteristics of bowel movements	Patients kept daily diaries about stool consistency and degree of straining severity during defecation.	3 months	No
Secondary	Constipation-related symptoms assessments	Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.	3 months	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 week 4 and 12.	3 months	No
Secondary	Colonic transit time measurements	Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.	3 months	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 was used. Patients kept daily diaries about the rescue medication when used.	3 months	No
Secondary	Adverse events	Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.	3 months	Yes