Treatment for Inflammatory Bowel Diseases

1
Effectiveness
1
Safety
Children's Hospital of Orange County, Orange, CA
Inflammatory Bowel Diseases
Eligibility
< 65
All Sexes
Eligible conditions
Inflammatory Bowel Diseases

Study Summary

This study is evaluating whether a supplement of gangliosides can improve symptoms of IBD in children.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 5 secondary outcomes, and 10 other outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of Day 0.

Day 0
Albumin, study start
Hematocrit, study start
Hemoglobin, study start
Platelets, study start
White blood cells, study start
Day 70
Albumin, study end
C-reactive protein
Calprotectin
Disease activity index
Hematocrit, study end
Hemoglobin, study end
IMPACT-III questionnaire
ImproveCareNow Physician Global Assessment
Intestinal integrity
Platelets, study end
White blood cells, study end

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo
Placebo group

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment 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.

Placebo
Other
5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral.
Treatment
Other
5 grams of buttermilk powder daily for 10 weeks, oral.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 70
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 70 for reporting.

Closest Location

Children's Hospital of Orange County - Orange, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that mild-moderate IBD is defined by the ImproveCareNow (ICN) Physician Global Assessment (PGA) and severe IBD is defined by the ICN PGA if stable for at least 120 days. show original
Location of the disease in the small intestine, the large intestine, and the colon. show original
Participants age 9-21 years

Patient Q&A Section

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

How many people get inflammatory bowel diseases a year in the United States?

Add answer

About 1 in 7 Caucasian Americans and 1 in 10 Asians had an IBD in the 3 years after this meta-analysis. These associations were not seen in black and Hispanic Americans. Most people who got an IBD in the period, however, got it after they were older, not younger.

Unverified Answer

What are common treatments for inflammatory bowel diseases?

Add answer

There is considerable evidence that there is a need for therapeutic measures in the treatment of inflammatory bowel diseases (IBDs). There are multiple different treatment modalities available. Treatment is based on the disease type and the severity of the disease. The most common treatments include conventional anti-inflammatory and immunosuppressive medications, such as steroids, azathioprine, and methotrexate; and anti-TNF-based therapeutics such as infliximab and adalimumab/alectin; or, alternatively, biological therapy such as interleukin-10.

Unverified Answer

Can inflammatory bowel diseases be cured?

Add answer

Crohn's disease and ulcerative colitis can be treated, whereas their natural histories are not completely understood. The role of other treatments, such as anti-tumor necrosis factor or biological therapies, remains poorly understood.

Unverified Answer

What are the signs of inflammatory bowel diseases?

Add answer

IBDs and irritable bowel syndrome are two common chronic non-infectious colorectal diseases that share pathologic similarities. They show similar age distribution and clinical presentations, and it is important to distinguish them using the correct endoleak definition, biopsy findings, and relevant biomarkers.

Unverified Answer

What is inflammatory bowel diseases?

Add answer

IBD is a gastrointestinal disease characterised by an infiltration of the small and the large bowel by neutrophils and lymphocytes. This may not just be a functional disorder but may involve immunological disorders that could justify the name of immune-mediated intestinal disease.

Unverified Answer

What causes inflammatory bowel diseases?

Add answer

Inflammatory bowel disease is due to a number of reasons including genetic susceptibility, environmental triggers, immune dysfunction and intestinal inflammatory responses to a variety of things, including diet and infectious agents.

Unverified Answer

What is the average age someone gets inflammatory bowel diseases?

Add answer

This is the first time, to the best of our knowledge, that this is used to characterize the demographic properties of a population of patients with IBD. The findings suggest that, in our populations, Crohn's disease occurs most commonly in early or mid-adulthood, while ulcerative Colitis occurs more commonly in early adulthood. The findings also suggest that while the incidence of IBD is greatest among first-borns, it can occur in all age groups.

Unverified Answer

Have there been any new discoveries for treating inflammatory bowel diseases?

Add answer

There have been no new treatments for inflammatory bowel diseases in the last decade. Most new treatments in recent years have been aimed at controlling the symptoms that often accompany inflammatory bowel diseases, such as pain, diarrhea, and fatigue. Several agents are being developed to treat an increasing number of inflammatory bowel diseases. The list of promising new drugs included in publications in recent years for treating inflammatory bowel diseases or rheumatic conditions such as rheumatoid arthritis or psoriatic arthritis has nearly a thousand entries. The list is growing, but very little has been accomplished to treat the symptoms that are disabling for people with inflammatory bowel diseases or rheumatic conditions.

Unverified Answer

Is treatment safe for people?

Add answer

There is no convincing evidence that an effective IBD guideline can be developed without the consultation and consent of patients. The development of a guideline is reliant on patients' input. In developing guidelines, patients and clinicians should have equitable access to advice-seeking.

Unverified Answer

Does treatment improve quality of life for those with inflammatory bowel diseases?

Add answer

The data suggest that some quality of life aspects are affected differentially by treatments such as 5-ASA, azathioprine, corticosteroids, and immunomodulators. More research is needed to identify and delineate the treatment's effects on quality of life and whether different disease conditions have different qualities and sources.

Unverified Answer

Does inflammatory bowel diseases run in families?

Add answer

IBD runs in families and both CD and UC show positive epistatic effects between CD/UC and IBD, and between CD and UC. There was no significant association between IBD, either separately or combined in CD and UC, and SLE, RA, or OA.

Unverified Answer

What are the latest developments in treatment for therapeutic use?

Add answer

In terms of new drug therapies, there are many new compounds being studied for treatment of both inflammatory and immunological diseases. In terms of the novel biologic agents that are now being used, it seems that the biologics have the same role as in the past; that is immunosuppressive therapy for all systemic inflammatory diseases. Immunomodulators and biologics are used, although there is some controversy about their use due to some of the adverse consequences of these agents. In terms of novel non-biologic drug therapies, some patients may prove to be resistant due to mutations or polymorphisms in genes governing the drug absorption, distribution, and metabolism.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Inflammatory Bowel Diseases by sharing your contact details with the study coordinator.