Synbiotic for Ileocolitis

Phase-Based Estimates
1
Effectiveness
1
Safety
Grey Nuns Community Hospital, Edmonton, Canada
Ileocolitis+1 More
Synbiotic - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Ileocolitis

Study Summary

This study is evaluating whether a probiotic and fiber supplement can prevent disease recurrence in people with Crohn's disease.

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Eligible Conditions

  • Ileocolitis
  • Crohn Disease
  • Crohn's Disease (CD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Synbiotic will improve 1 primary outcome and 12 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Immediately post-surgery up to 7 days.

6-month period
Changes in fecal bile acids
Changes in fecal short chain fatty acids
Changes in intestinal barrier function
Changes in intestinal inflammation
Changes in quality of life (1)
Changes in quality of life (2)
Changes in systemic inflammation
Changes in the fecal microbiota composition
Prevention of clinical recurrence
Prevention of endoscopic recurrence
The percentage of participants who experience treatment emergent adverse and serious adverse events
Day 7
Time to first bowel movement
Day 30
Time to hospital discharge

Trial Safety

Side Effects for

Sevelamer
Mouth Ulcers
14%
Abdominal Bloating/Flatulence
14%
Nausea
14%
Vasovagal Syncope
14%
Hypertension
0%
Headache
0%
Dehydration
0%
Ear Itching
0%
Diarrhea
0%
Hematoma
0%
Gum Infection
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02124759) in the Sevelamer ARM group. Side effects include: Mouth Ulcers with 14%, Abdominal Bloating/Flatulence with 14%, Nausea with 14%, Vasovagal Syncope with 14%, Hypertension with 0%.

Trial Design

2 Treatment Groups

Digestible Maltodextrin
Synbiotic
Placebo group

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. Synbiotic is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Synbiotic
DietarySupplement
Bifidobacterium longum spp. longum R0175, Bifidobacterium animalis spp. Lafti B94, Bifidobacterium bifidum R0071 at 3x10^9 CFU/d plus resistant starch type 2, arabinoxylan, and galactooligosaccharide at 24 g/d will serve as the treatment.
Digestible Maltodextrin
Other
Digestible maltodextrin will serve as the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Synbiotic
2016
Completed Phase 3
~700

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-month period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-month period for reporting.

Closest Location

Grey Nuns Community Hospital - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Ileocolitis or the other condition listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
surgery cured my Crohn's disease My Crohn's disease was cured by undergoing ileocolonic resection surgery. show original
Females who might become pregnant must use contraception approved by a doctor and have a negative pregnancy test at screening and baseline. show original
Diagnosis of Crohn's disease

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes ileocolitis?

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There is no obvious cause because there is no identifiable infection that would trigger the autoimmune disease. In all likelihood, the cause of ileocolitis can be due to some change in the gut microbiota that the body does not make an appropriate immune response for.

Unverified Answer

Can ileocolitis be cured?

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In the treatment of pouchitis with an ileostomy reversal, more than 86% of patients with persistent inflammatory ileal symptoms and/or endoscopically visible pouch inflammation respond within 2 years to a successful surgical procedure.

Unverified Answer

What are common treatments for ileocolitis?

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There are a variety of procedures that are used to treat ileocolitis. Colonoscopy is often performed to document the extent of the disease and check for adenocarcinomas. Surgery is often done in order to excise the diseased area. A variety of non-surgical, non-medical procedures can also be used to treat the disease. It must be emphasized that the goals of treatment for ileocolitis are to minimize the amount of symptoms and the effects of the disease and to minimize the side effects of any medication or non medical treatment. This article also emphasizes the importance of a well-balanced diet to help treat the disease. This can help with relieving any vomiting or diarrhea that occurs from the disease.

Unverified Answer

What are the signs of ileocolitis?

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Anorectal and non-recurrent abdominal pain and diarrhea are possible symptoms in both colitis and ileocolitis. For the diagnosis of pouchitis, symptoms should be present for at least 2 weeks or, if remission is achieved, for 3 weeks.\n

Unverified Answer

What is ileocolitis?

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The onset of UC is typically earlier in CD than in UC; however, the onset of UC in IBD is later than for UC and most likely happens in the elderly. Elderly patients with IBD have less flares during their course and a better response to medical treatment.

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How many people get ileocolitis a year in the United States?

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A high proportion of patients with ileocolitis seen in gastroenterology clinic have CD. Although CD is the most common explanation for ileocolitis, some patients with ileocolitis without CD have ileal biopsies demonstrating histologic features suggestive of CD. Results from a recent paper suggest that one might expect to see 5 to 10 cases per year of patients with ileocolitis, possibly with a predilection for women. [Power] This can be found in clinicaltrials.gov for clinical trials tailored to this condition.

Unverified Answer

Have there been other clinical trials involving synbiotic?

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The synbiotic used in this study might be a safer, but equivalent, alternative to the usual probiotic treatments for ileocolitis and [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis). This treatment in combination with conventional therapy should be evaluated and compared in future randomized controlled trials to confirm the results obtained in this study.

Unverified Answer

What is the latest research for ileocolitis?

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There is an ongoing gap between current practice and the research we summarize. We urge our specialists to take a closer look at ileocolitis and to consider referral for participation in clinical trials.

Unverified Answer

Who should consider clinical trials for ileocolitis?

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There is a huge demand for new treatments for ileocolitis and the demand may be increasing. Clinical studies have been performed on post-surgical patients and in patients with Crohn's disease. However, it remains unclear which patients are most likely to benefit and which are most likely to experience severe adverse events, leading to abandonment of a study. There is a large variation in the response people with Ileocolitis have to treatment and it is reasonable to consider clinical studies only in selected cases or only in those with moderate response.

Unverified Answer

What is the average age someone gets ileocolitis?

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The average age someone is diagnosed is 53 years. The average age of onset is 58 years and the average onset of a pouch is 73 years or later.

Unverified Answer

What are the latest developments in synbiotic for therapeutic use?

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New formulations of synbiotics have been developed in recent years and have promising results in improving parameters of intestinal inflammation and improving outcomes of patients with ileocolitis. In addition, in the current literature, new and promising data are presented regarding the therapeutic and immunomodulative effects of synbiosis.

Unverified Answer

How serious can ileocolitis be?

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Contrary to expectations, ileocolitis appeared to be potentially more severe than ulcerative colitis. Both syndromes were associated with a higher incidence of colectomy, longer LOS, and higher rates of complications during hospitalisation than UC. The effect of ileocolitis on the patient and healthcare system needs to be considered during management of the disease.

Unverified Answer
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