Disorientation as to People, Time and PlaceNCT02336789
Proposal to Examine the Effect of Fecal Transplantation on Obesity
A study testing fecal material and normal saline in people with Disorientation as to People, Time and Place, run by Kaplan Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorientation as to People, Time and Place
- What is being tested?
- fecal material and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot, 76100
Ali Abdullah, MD, 089441370
About this study
Official title: Proposal to Examine the Effect of Fecal Transplantation on Obesity.
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.
Read more
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.
Read the 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.
- Being tested
- fecal material, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal materialOther
. 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).
normal salineOther
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).
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 250 ml of normal saline (sham transplantation). Receives: Other: normal saline |
| intervention | Active comparator | 250 ml of diluted fecal material prepared from a screened donor Receives: Other: fecal material |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorientation as to People, Time and PlaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Malnick, Kaplan Medical Center
- Investigators
- Stephen DH Malnick, MD, Principal investigator, Kaplan Medical CenterEhud Melzer, MD, Study director, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336789
- Sponsor's protocol ID
- 0088-14-KMC
- Status last verified
- Dec 2014
- First submitted
- 8 Jan 2015
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal to Examine the Effect of Fecal Transplantation on Obesity.
- ClinicalTrials.gov ID
- NCT02336789
- Acronym / sponsor ID
- 0088-14-KMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: normal saline250 ml of normal saline (sham transplantation). |
| intervention | Active comparator | Other: fecal material250 ml of diluted fecal material prepared from a screened donor |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | intervention |
| normal salineAll 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). | Other | placebo |
Primary outcome
weight loss
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen DH Malnick, MD principal investigator
Kaplan Medical Center
Ehud Melzer, MD study director
Kaplan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fecal material and normal saline in people with Disorientation as to People, Time and Place, run by Kaplan Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehud Melzer, MD (97289441846, ehudm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.