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Ulcerative Colitis (UC)NCT02217722

Use of the Ulcerative Colitis Diet for Induction of Remission

A study testing Ulcerative Colitis Diet and Antibiotic cocktail in people with Ulcerative Colitis (UC), run by Prof. Arie Levine at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Ulcerative Colitis Diet and Antibiotic cocktail
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteIsrael
Study dates
Oct 2014to Feb 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 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Informed consent
  • Established diagnosis of UC disease.
  • Age: 5 - 18 years ( inclusive)
  • Mild to moderate active disease, 10 ≤ PUCAI ≤45.
  • Stable medication (IMM/ 5ASA) use for the past 6 weeks.
  • For patients who received antibiotic treatment: age 10-18 (inclusive).

Who cannot join

  • Any proven infection such as positive stool culture, parasite or C.difficile.
  • Use of Antibiotics
  • Use of steroids in the previous two weeks only
  • Patients that are refractory to full dose steroids ( 1 mg/kg/day)
  • Past acute severe UC.
  • Current Extra intestinal manifestation of UC.
Show all 9Show fewer
  • Pregnancy.
  • A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study.
  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • The E.Wolfson Medical Center

    Holon, 58100

Other trials in Israel

About this study

Official title: An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission.

The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.

Read the detailed description

Background:

Recent research has shown that dietary components may lead to impaired intestinal innate immunity due to alterations in the microbiome, mucous layer, intestinal permeability or change in bacterial adherence and translocation. Pfeffer Gik et al (Dig Dis, 2014) compiled a list of food components and additives that impair the intestinal epitheliums ability to contain bacteria to the lumen, and consequently increase intestinal permeability which, in turn, increases the uptake of luminal antigens and microbial factors. The list includes Gliadin, Saturated fat milks, emulsifiers such as Carboxymethylcellulose, Polysorbate 80 and Sodium Caprate )Levine A, Wine E, 2013). In Crohn's disease, intervention with EEN or a Crohn's disease exclusion diet have shown high rates of remission in mild- moderate CD patients. The CDED led to remission in 70% of patients, primarily with patients with early mild to moderate disease (Sigall-Boneh R et al, 2014).

Unlike CD, none of these studies have systematically examined the relationship between normal diet intake and relapses in UC. Devotka et al demonstrated that a bloom in sulphide reducing bacteria increased colitis in IL10-/- mice. This was due to increased Bilophila Wadsworthia which is sulphide dependent (Brown k et al, 2012). Studies have shown that the rate of butyrate utilization in normal specimens was almost double than that found in UC Specimens. Moreover, high fiber diet can affect the microbial composition (Pitcher MCL et al, Gut, 2000) and regulatory T cells in the colon (Singh N et al, 2014).

Until recently, UC was not considered to be a bacteria mediated disease. However, our increased understanding of UC indicates that bacteria might have a role in pathogenesis or severity of the disease. The strongest evidence comes from Japanese studies in patients with moderate to severe colitis, which demonstrated that triple therapy with penicillin , tetracycline and metronidazole led to remission in steroid refractory patients in 60% of patients, and this was reproduced in a follow up randomized controlled trial which showed a 70% remission rate (UEGW Amsterdam 2012, Ohkusa T et al 2005 ). On the other hand a previous trial had shown 44% response and only (Ohkusa T et al 2010). A recent retrospective study in Israel showed a 65% response and 50% remission rate in patients with severe refractory colitis. Thus it is unclear at present if antibiotics are useful only in severe colitis , or if this reflects heterogeneity among studies.

Diet and antibiotics are the two proven treatments that may alter the microbiota clinically. Theoretically, controlling the microbiota by diet or antibiotics may allow for control of the disease without immune suppression , and this has yet to be evaluated.

Based on our previous success in improving remission and decreasing inflammation with a novel dietary intervention in Crohn's disease, and based on these previously mentioned studies, we have postulated that a diet could be beneficial for patients with Ulcerative Colitis. We further hypothesize that patients failing diet might respond to antibiotic therapy If patients respond to the diet this would have an immediate impact and be the first evidence for a specific diet that works in UC. If the diet fails and the antibiotics succeed, this would be the first evidence for the effect of oral antibiotics in mild disease .

Being tested
Ulcerative Colitis Diet, Antibiotic cocktail
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ulcerative Colitis DietOther

    we have postulated that a diet that increases butyrate through fiber exposure, reduces intestinal sulfur exposure, and increases vitamin D levels could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.

  • Antibiotic cocktailDrug

    Also called Doxycyclin, amoxicillin and metronidazole

    We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression

Study groups in NCT02217722
Study groupRoleWhat they receive
Ulcerative Colitis Diet counselingExperimentalPatients will receive a structured novel diet termed the UCD for 6 weeks. . patients that completed induction phase with remission(PUCAI<10) will be asked if they are willing to adhere to the UCD for an additional 20 weeks.
Receives: Other: Ulcerative Colitis Diet
Antibiotic TreatmentExperimentalPatients failing to enter or maintain remission by 6 weeks, or with worsening disease at any time after week 2 will be considered failures on an intention to treat basis. Eligible patients at this time at aged 10 or above may receive a 14 day antibiotic course with Doxycycline, amoxicillin and metronidazole.In addition to the description above children who refused to UCD or with low adherence to UCD may be enrolled directly to this arm.
Receives: Drug: Antibiotic cocktail

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission rate, defined as a PUCAI less than 10 at week 6.

    Measured: week 6

Secondary outcomes (2)
  1. Change in Mean PUCAI week 6.

    Measured: week 6

  2. Change in mean Calprotectin week 6

    Measured: week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionFeb 2016

Why it stopped: We have submitted a multi center study, with the same nutritional therapy

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217722
Sponsor's protocol ID
0096-14-WOMC
Status last verified
Aug 2016
First submitted
20 Jul 2014
Last updated
11 Aug 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Ulcerative Colitis Diet and Antibiotic cocktail in people with Ulcerative Colitis (UC), run by Prof. Arie Levine 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 6 inclusion and 9 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 11 Aug 2016. 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?

The study was stopped early (reason given: We have submitted a multi center study, with the same nutritional therapy). 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?

Remission rate, defined as a PUCAI less than 10 at week 6. (time frame: week 6). 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 11 Aug 2016.

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