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Proposal to Examine the Effect of Fecal Transplantation on Obesity

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ClinicalTrials.gov Identifier: NCT02336789
Recruitment Status : Unknown
Verified December 2014 by Stephen Malnick, Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Stephen Malnick, Kaplan Medical Center

Brief Summary:

The investigators propose to transplant feces from thin, disease-free donors into obese patients undergoing colonoscopy for screening for colorectal carcinoma.

The investigators will obtain feces from healthy donors with a BMI of between 21-24. The investigators will perform colonoscopy on healthy patients with a BMI of 30-40 kg/m2 who have a clear indication for a screening examination.

All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation).

The patients will be reviewed at 1 3 6 and 12 months. At this time note will be made of their weight, BMI and waist circumference. In addition note will be made of their fasting glucose and lipid profile.


Condition or disease Intervention/treatment Phase
Disorientation as to People, Time and Place Other: fecal material Other: normal saline Not Applicable

Detailed Description:

We propose to transplant feces from thin, disease-free donors into obese patients undergoing colonoscopy for screening for colorectal carcinoma.

We will obtain feces from healthy donors with a BMI of between 21-24, in accordance with the Protocol that was approved by the Israel Ministry of Health. The stool sample will be prepared as detailed below :

We will perform colonoscopy on healthy patients with a BMI of 30-40 kg/m2 who have a clear indication for a screening examination. These will be people who are above the age of 50 who have not had a screening colonoscopy in the last 10 years, or those with a family history of carcinoma of the colon who are over the age of 40 years.

All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation). The material will be injected in the amount of 50 ml at five locations- the terminal ileum (or the cecum if the terminal ileum cannot be intubated), ascending colon, transverse colon, descending colon and sigmoid colon- during withdrawal of the colonoscope from the cecum. The stool will not be delivered to the endoscopy suite until the patient is sedated and only the endoscopist performing the procedure will know what treatment arm the patient is in.

In addition, all patients participating in the study will receive standard advice regarding weight loss and physical activity (at least 90 minutes of walking for week) from a staff dietitian.

Stool samples will be obtained from the donor( from the stool donated for transplantation) and the patients at baseline (prior to transplantation), 1 month and 12 months and frozen at -80 C for high throughput analysis by standard techniques.

The patients will be reviewed at 1 3 6 and 12 months. At this time note will be made of their weight, BMI and waist circumference. In addition note will be made of their fasting glucose and lipid profile.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Proposal to Examine the Effect of Fecal Transplantation on Obesity.
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Placebo Comparator: placebo
250 ml of normal saline (sham transplantation).
Other: normal saline
All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation).

Active Comparator: intervention
250 ml of diluted fecal material prepared from a screened donor
Other: fecal material
. All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation).




Primary Outcome Measures :
  1. weight loss [ Time Frame: one year ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy patients with a BMI of 30-40 kg/m2 who have a clear indication for a screening examination. These will be people who are above the age of 50 who have not had a screening colonoscopy in the last 10 years, or those with a family history of carcinoma of the colon who are over the age of 40 years.

Exclusion Criteria:

  • Exclusion criteria include hepatitis B and C infection,
  • consumption of more than 20 gram of alcohol per day,
  • diabetes mellitus treated with insulin,
  • previous unstable coronary artery disease in the last year,
  • HIV infection,
  • concomitant use of corticosteroids in the previous 3 months and severe diverticulosis.

If patients were to receive antibiotic therapy during the year of follow up of the study, data will only be included in the analysis prior to this time.


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): NCT02336789


Contacts
Contact: Ehud Melzer, MD 97289441846 ehudm@clalit.org.il
Contact: Stephen DH Malnick, MD 97289441371 stephen@malnick.net

Locations
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Ali Abdullah, MD    089441370      
Sponsors and Collaborators
Kaplan Medical Center
Investigators
Principal Investigator: Stephen DH Malnick, MD Kaplan Medical Center
Study Director: Ehud Melzer, MD Kaplan Medical Center

Responsible Party: Stephen Malnick, doctor, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02336789     History of Changes
Other Study ID Numbers: 0088-14-KMC
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms