Gastrointestinal ComplaintsNCT01022385
The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy
A study testing 24-hour low-residual diet in people with Gastrointestinal Complaints, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Complaints
- What is being tested?
- 24-hour low-residual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Dec 2011
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients who will submitted to capsule endoscopy due to following medical indications:
- suspected Crohn's disease
- obscure GI bleeding
- iron deficiency anemia
- suspected malabsorption disease
- unexplained abdominal pain
- unexplained chronic diarrhea
Who cannot join
- pregnancy
- patients who had previous surgery on Gastrointestinal tract
- patients with previous intestinal obstruction
- patients who will refuse to participate in the study
- diabetes mellitus
- known celiac disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.
- Conditions
- Gastrointestinal Complaints
- Being tested
- 24-hour low-residual diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour low-residual dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 12-hour fast | No intervention | Not described |
| 24-hour low-residual diet and 12-hour fast | Active comparator | Not described Receives: Dietary Supplement: 24-hour low-residual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleanliness and better visualization of the small bowel during capsule endoscopy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplaintsStudies 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
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022385
- Sponsor's protocol ID
- 0064-08-HYMC
- Status last verified
- Nov 2009
- First submitted
- 26 Nov 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT01022385
- Acronym / sponsor ID
- 0064-08-HYMC
- Conditions
- Gastrointestinal Complaints
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Dec 2009 (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 aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.
Study design
- Primary purpose
- Diagnosis
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-hour fast | No intervention | – |
| 24-hour low-residual diet and 12-hour fast | Active comparator | Dietary Supplement: 24-hour low-residual diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consecutive patients who will submitted to capsule endoscopy due to following medical indications:
Key exclusion criteria (6 listed)
- pregnancy
- patients who had previous surgery on Gastrointestinal tract
- patients with previous intestinal obstruction
- patients who will refuse to participate in the study
- diabetes mellitus
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 |
|---|---|---|
| 24-hour low-residual diet | Dietary supplement | 24-hour low-residual diet and 12-hour fast |
Primary outcome
Cleanliness and better visualization of the small bowel during capsule endoscopy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-hour low-residual diet in people with Gastrointestinal Complaints, run by Hillel Yaffe 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 7 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 1 Dec 2009. 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.
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 Eva Niv, MD (972-4-630-4408, evan@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleanliness and better visualization of the small bowel during capsule endoscopy (time frame: 2 years). 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 1 Dec 2009.