Colon PreparationPhase 2NCT00749905
Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
A Phase 2 study testing low fiber diet and regular diet in people with Colon Preparation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Colon Preparation
- What is being tested?
- low fiber diet and regular diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 2
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <75
- Colon study indicated for colo-rectal carcinoma screening
- After colonoscopy for any indication failed due to technical causes
- Patients who decline an indicated colonoscopy
Who cannot join
- Significant heart failure (NYHA grade III-IV)
- Renal failure (Creatinine > 1.2 mg/dl)
- Known or suspected intestinal strictures
- Known or suspected mesenteric adhesions
- History suggestive of bowel obstruction
- Vomiting and/or aspirations
Show all 12Show fewer
- Symptoms of dysphagia
- Pace-maker or AICD implanted
- Known allergy or intolerance to any of the study drugs
- Pregnancy
- Illicit drug abuse or alcoholism
- Inability to provide an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination
- Conditions
- Colon Preparation
- Being tested
- low fiber diet, regular diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fiber dietOther
Low fiber diet for 5 days prior to colon capsule
regular dietOther
Regular diet until 1 day before colon capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low fiber diet for 5 days prior to procedure Receives: Other: low fiber diet |
| 2 | Active comparator | regular diet Receives: Other: regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon cleanliness
Measured: one week from capsule examination
Secondary outcomes (1)
Tolerability of preparations
Measured: within 1 day of completing preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionDec 2009
Why it stopped: was not able to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PreparationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Shomron BenHorin, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749905
- Sponsor's protocol ID
- SHEBA-08-5217-SBH-CTIL
- Status last verified
- Jun 2018
- First submitted
- 8 Sep 2008
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
- ClinicalTrials.gov ID
- NCT00749905
- Acronym / sponsor ID
- SHEBA-08-5217-SBH-CTIL
- Conditions
- Colon Preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: was not able to recruit enough patients
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2009 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Sep 2008 (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.
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: low fiber dietLow fiber diet for 5 days prior to procedure |
| 2 | Active comparator | Other: regular dietregular diet |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 and <75
- Colon study indicated for colo-rectal carcinoma screening
- After colonoscopy for any indication failed due to technical causes
- Patients who decline an indicated colonoscopy
Key exclusion criteria (12 listed)
- Significant heart failure (NYHA grade III-IV)
- Renal failure (Creatinine > 1.2 mg/dl)
- Known or suspected intestinal strictures
- Known or suspected mesenteric adhesions
- History suggestive of bowel obstruction
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 |
|---|---|---|
| low fiber dietLow fiber diet for 5 days prior to colon capsule | Other | 1 |
| regular dietRegular diet until 1 day before colon capsule | Other | 2 |
Primary outcome
Colon cleanliness
Time frame: one week from capsule examination
1 secondary outcome
Tolerability of preparations
Time frame: within 1 day of completing preparation
Results and safety
The study was stopped early (reason given: was not able to recruit enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low fiber diet and regular diet in people with Colon Preparation, run by Sheba 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Jun 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: was not able to recruit enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon cleanliness (time frame: one week from capsule examination). 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 14 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.