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Immunoglobulin

Serum Bovine Immunoglobulin for Inflammatory Bowel Disease

Q: Does this experiment seek participants who are thirty or older?

According to the requirements of this medical experiment, candidates must be between 6 and 30 years old. In addition, there are 130 trials that target children younger than 18 and 421 for adults over 65.

Q: How many participants have been enrolled in this experiment?

Affirmative. According to clinicaltrials.gov, the study that was initially posted on September 20th 2020 is currently recruiting participants. 43 subjects need to be enrolled from 1 centre for this research project.

Q: What kind of participants would be most ideal for this trial?

To qualify for this research, applicants must have ileocolitis and fall between 6 to 30 years of age. Currently, 43 participants are needed for the trial.

Q: Are there opportunities to join this trial at present?

Affirmative. Clinicaltrials.gov confirms that the research, which was initially uploaded on September 20th 2020, is now actively recruiting for 43 subjects from 1 medical centre.

Phase < 1

Recruiting

Led By Monisha Shah, M.D.

Research Sponsored by Monisha Hitesh Shah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 15, 60 and 90

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a protein powder made from cow serum, to see if it can help improve symptoms in children and young adults with inflammatory bowel disease.

Eligible Conditions

Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 15, 60 and 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0, 15, 60 and 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 15, 60 and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease

Secondary outcome measures

Effect of SBI on disease activity (CRP)

Effect of SBI on disease activity (ESR)

Effect of SBI on disease activity (calprotectin)

+10 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Serum Bovine ImmunoglobulinActive Control1 Intervention

Study product: Serum bovine immunoglobulin, also known by the trade name of Enteragam Dosage form: powdered packet Dosage: Each packet (10 g net weight) consists of 5 g of serum-derived bovine immunoglobulin/protein isolate (SBI) which is the active ingredient Frequency: one packet a day Duration: 60 days

Group II: Hydrolyzed CollagenPlacebo Group1 Intervention

Placebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Monisha Hitesh ShahLead Sponsor

Monisha Shah, M.D.Principal InvestigatorThe University of Texas Health Science Center, Houston

Jon Marc Rhoads, M.D.Study DirectorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

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

Does this experiment seek participants who are thirty or older?

"According to the requirements of this medical experiment, candidates must be between 6 and 30 years old. In addition, there are 130 trials that target children younger than 18 and 421 for adults over 65."

Answered by AI

How many participants have been enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, the study that was initially posted on September 20th 2020 is currently recruiting participants. 43 subjects need to be enrolled from 1 centre for this research project."

Answered by AI

What kind of participants would be most ideal for this trial?

"To qualify for this research, applicants must have ileocolitis and fall between 6 to 30 years of age. Currently, 43 participants are needed for the trial."

Answered by AI

Are there opportunities to join this trial at present?

"Affirmative. Clinicaltrials.gov confirms that the research, which was initially uploaded on September 20th 2020, is now actively recruiting for 43 subjects from 1 medical centre."

Answered by AI

Recent research and studies

Patient Preference and AdherenceJournal

Impact of Serum-derived Bovine Immunoglobulin/protein Isolate Therapy on Irritable Bowel Syndrome and Inflammatory Bowel Disease: A Survey of Patient Perspective

Shaw, Audrey, Adam Tomanelli, Timothy Bradshaw, Bryon Petschow, and Bruce Burnett. 2017. “Impact of Serum-derived Bovine Immunoglobulin/protein Isolate Therapy on Irritable Bowel Syndrome and Inflammatory Bowel Disease: A Survey of Patient Perspective”. Patient Preference and Adherence. Informa UK Limited. doi:10.2147/ppa.s134792.

The American Journal of the Medical SciencesJournal

Clinical Efficacy of Serum-derived Bovine Immunoglobulin in Patients with Refractory Inflammatory Bowel Disease

Liaquat, Hammad, Munish Ashat, Abigail Stocker, Lindsay McElmurray, Karen Beatty, Thomas L. Abell, and Gerald Dryden. 2018. “Clinical Efficacy of Serum-derived Bovine Immunoglobulin in Patients with Refractory Inflammatory Bowel Disease”. The American Journal of the Medical Sciences. Elsevier BV. doi:10.1016/j.amjms.2018.08.019.

Pediatric Health, Medicine and TherapeuticsJournal

Serum-derived Bovine Immunoglobulin for Children with Diarrhea-predominant Irritable Bowel Syndrome

Arrouk, Rami, Rachel E Herdes, Aryn C Karpinski, and Paul E Hyman. 2018. “Serum-derived Bovine Immunoglobulin for Children with Diarrhea-predominant Irritable Bowel Syndrome”. Pediatric Health, Medicine and Therapeutics. Informa UK Limited. doi:10.2147/phmt.s159925.

Physiological ReportsJournal