Diet-CD for Ileocolitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Massachusetts Medical School, Worcester, MA
Ileocolitis+1 More
Diet-CD - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a diet change during pregnancy may help prevent Crohn's disease in infants.

See full description

Eligible Conditions

  • Ileocolitis
  • Pregnant State

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Diet-CD will improve 1 primary outcome and 7 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of 3 months.

3 months
The Rome IV Criteria
4 Years
Alternative Healthy Eating Index
Calprotectin level
Harvey Bradshaw index (HBI)
SF-12
The Bristol Stool Form Scale
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
Baseline and 4 Years
Change in overall number of proteobacteria

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

No-Diet-Control
1 of 3
No-Diet-CD
1 of 3
Diet-CD
1 of 3
Active Control
Experimental Treatment

This trial requires 396 total participants across 3 different treatment groups

This trial involves 3 different treatments. Diet-CD is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Diet-CD
Other
dietary intervention: 8-10 weeks of diet intervention
No-Diet-ControlUnaffected controls at the same gestational stage will follow usual diet and no intervention
No-Diet-CDUsual diet with no intervention

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Who is running the study

Principal Investigator
I. P.
Prof. Inga Peter, Professor
Icahn School of Medicine at Mount Sinai

Closest Location

University of Massachusetts Medical School - Worcester, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Ileocolitis or the other condition listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Capacity to sign informed consent
At least 18 years old
Singleton pregnancy of less than 27-29 weeks gestation
English-speaking

Patient Q&A Section

What are the signs of ileocolitis?

"It is the most common cause of the lower gastrointestinal tract symptoms in the patient with inflammatory bowel disease (IBD). Signs and symptoms can be present from any of the bowel segments and they are often a delay in making the diagnosis of CD." - Anonymous Online Contributor

Unverified Answer

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

"These numbers illustrate the number of new and potentially newly diagnosed patients and the frequency of the diagnosis of UC. The number of new diagnoses in the US is not consistent with the true incidence of ileocolitis." - Anonymous Online Contributor

Unverified Answer

What causes ileocolitis?

"The ileum and the colon are tightly controlled by a complicated network of nerve inputs, enteric nervous system components, and cytokines. This network can be disrupted by a myriad of factors, and such disruptions may underlie the development of inflammatory bowel diseases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ileocolitis?

"Specific treatment regimens for ileocolitis often change with each edition of the Rome III Criteria and/or revisions in ICD-10. In general, treatment of ileocolitis will include a combination of diet, antibiotic, and/or surgery. Steroid monotherapy seems to be a commonly used treatment especially in some parts of the world, with the most recent study showing an overall response rate of 50%. On the other hand, some studies have also demonstrated that steroid therapy was not effective in preventing hospitalization due to UC/CD recurrence." - Anonymous Online Contributor

Unverified Answer

Can ileocolitis be cured?

"[Though the long-term benefits of surgery might not always be obvious on the basis of short term studies, and even when these treatments show good short-term (1 year) results, there is the risk of relapse with long-term complications, which leads to many patients opting out of treatment. If a cure is possible, the cost is small compared with the benefits, and there is the risk of [death after surgery if one does not undergo a total colectomy] and with further surgical interventions in the future." - Anonymous Online Contributor

Unverified Answer

What is ileocolitis?

"The diagnosis of ileocolitis is challenging but when it does occur there is a need for the use of a specific scoring system. In summary, the symptoms of ileocolitis are severe abdominal pain, diarrhoea without dehydration and fever." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of ileocolitis?

"Non-infectious causes can be equally responsible for idiopathic ileocolitis and infectious diseases in patients with chronic diarrhea. This may explain the good response to antibiotics in some patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in diet-cd for therapeutic use?

"The current therapies and studies are progressing in the clinical management and treatment of ulcerative colitis by modifying the diet. Dietary modifications and medications may improve the symptomatology of this disease. However, the underlying processes in inflammatory bowel disease must be better understood to permit the development of appropriate treatment strategies." - Anonymous Online Contributor

Unverified Answer

What does diet-cd usually treat?

"Many patients respond to dietary fat restriction plus a strict low-fat diet, an effect that is enhanced when patients are instructed to decrease dietary fat intake, although it is not always effective for all patients. More studies are needed to establish the long-term efficacy of this treatment regimen for diet-cd." - Anonymous Online Contributor

Unverified Answer

What is diet-cd?

"Food-based enteric challenges are effective in improving ileal permeability and in reversing ileal mucosal inflammation and bacterial translocation. This clinical study is the first to examine the effectiveness of a food-based enteric challenge as an alternative treatment for active CD. Clinically relevant food-based enteric challenge treatment seems to be a promising tool to alleviate symptoms of CD without the use of GFDs, medications or other treatments." - Anonymous Online Contributor

Unverified Answer

How serious can ileocolitis be?

"This is a serious condition that may adversely affect anyone with severe ileocolitis. If a patient presents in an acute setting with severe ileocolitis, the presenting features of illness, a rapid response to antibiotics and intravenous fluids, and signs of septic shock should alert the intern to the diagnosis. Patients with chronic ileocolitis may present with a similar set of symptoms as those with acute ileitis. The symptoms, however, may be subtle and can not necessarily be distinguished based on the clinical findings. These patients need close monitoring and aggressive medical management must be initiated as soon as they present with symptoms of illness." - Anonymous Online Contributor

Unverified Answer

What is the latest research for ileocolitis?

"Ileocolitis has become a major healthcare issue. Current treatment for IBD is directed at reducing the number and severity of episodes of flares. At times, patients must be put on long-term medications that negatively influence quality of life with increased risk of infections, malignancies, and drug-drug interactions. Current research has yielded few results in terms of new treatments or agents for Ileocolitis. Despite recent advances in our understanding of the pathogenesis and cellular interactions associated with it, little is known about its pathogenesis, the genetic and environmental factors that influence its occurrence, and the impact on healthcare resources." - Anonymous Online Contributor

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