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Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

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ClinicalTrials.gov Identifier: NCT02291354
Recruitment Status : Unknown
Verified November 2015 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Brief Summary:
The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal Microbiota Transplantation in Adult Patients with Slow Transit Constipation.

Condition or disease Intervention/treatment Phase
Slow Transit Constipation Drug: Pectin Other: Placebo Procedure: Fecal microbiota transplantation (FMT) Phase 2

Detailed Description:

Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Recent evidence in the literature and collected in our laboratory confirm that constipation can be a consequence of intestinal dysbiosis, which may affect the motility and metabolic environment of colon.

Fecal Microbiota Transplantation (FMT) is temporarily effective for patients with slow transit constipation. However, the transplanted microflora cannot maintain for a long time. Along with the gut microbiota returning to the original state, the symptoms relapse.

Pectin is a kind of soluble dietary fiber, producing short chain fatty acids (SCFAs) after a series of fermentation by gut flora to supply the energy for epithelial cells, regulate intestinal PH, promote intestinal motility and join effort in immune regulation with intestinal lymphoid tissue. Therefore, we conceive that pectin could promote the colonization of probiotics and reduce adhesion of pathogens.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pectin

Arm Intervention/treatment
Placebo Comparator: FMT + Placebo
Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.
Other: Placebo
Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks.

Procedure: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy

Experimental: FMT + Pectin
Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.
Drug: Pectin
Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks.
Other Name: soluble dietary fiber

Procedure: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy




Primary Outcome Measures :
  1. Proportion of patients having on average three or more SCBMs/week [ Time Frame: 12 weeks ]
    Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.


Secondary Outcome Measures :
  1. Bowel habit assessments [ Time Frame: 12 weeks ]
    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.

  2. Constipation-related symptoms assessments [ Time Frame: 12 weeks ]
    Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.

  3. Quality-of-Life assessments [ Time Frame: 12 weeks ]
    Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PACQOL) self-report questionnaire at week 4 and 12.

  4. Colonic transit time measurements [ Time Frame: 12 weeks ]
    Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.

  5. Usage of laxatives or enemas as rescue medication [ Time Frame: 12 weeks ]
    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.

  6. Adverse events [ Time Frame: 12 weeks ]
    Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291354


Contacts
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Contact: Jianfeng Gong, MD +86-25-80860036 jinlingh_gongjf@126.com
Contact: Ning Li, MD +86-25-80860089 jinlingh_lining@126.com

Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Ning Li, MD    +86-25-80860089    jinlingh_lining@126.com   
Principal Investigator: Jianfeng Gong, MD         
Sub-Investigator: Chao Ding, MD candidate         
Sub-Investigator: Hongliang Tian, PhD candidate         
Sub-Investigator: Xiaolong Ge, MD candidate         
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Ning Li, MD Department of Generay Surgery, Jinling hosptal

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Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02291354     History of Changes
Other Study ID Numbers: RIGS-Pectin-STC-2015
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: November 2015

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Fecal Microbiota Transplantation
Soluble Dietary Fiber
Slow Transit Constipation

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms