Diarrhea Predominant Irritable Bowel SyndromeNCT02358694
Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS
A study testing Serum-Derived Bovine Immunoglobulin in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D. Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diarrhea Predominant Irritable Bowel Syndrome
- What is being tested?
- Serum-Derived Bovine Immunoglobulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2014to 1 Jun 2015
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients > 8 years of age and < 18 years of age
- Patients with a diagnosis of IBS-D as per Rome III criteria
- Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
- Patients with normal fecal calprotectin and lactose hydrogen breath test
- Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
- Ability to complete the study
- Patients on stable doses or other medications for at least 4 weeks prior to enrollment
Who cannot join
- Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
- Patients with family history of inflammatory bowel disease
- Patients with history of abdominal surgery
- Patient with history of drug or alcohol abuse
- Patient with a history of allergy to study related products (e.g. beef)
- Use of probiotics in the previous month
- Patients who used SBI in the past
- Patients with soy allergy/sensitivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Childrens Medical Center
Farmington, Connecticut, 06106
About this study
Official title: Safety and Tolerability of Serum-Derived Bovine Immunoglobulin in Children With Diarrhea-Predominant Irritable Bowel Syndrome
This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D.
Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.
Read the detailed description
The study will consist of four phases:
Screening Phase: screen the patients for 2 weeks prior to enrollment in the study to establish objective criteria of disease presence and severity. Patients will maintain a daily symptom dairy. At the end of screening phase, we will calculate their quality of life and symptom severity scores based on the information provided by the patients and their family. Patients with an average score of 1 or greater over 14 days for abdominal pain and stool consistency will be selected for the open label trial of SBI.
Open Label Treatment Phase: patients enrolled will receive 4 weeks of SBI along with QOL questionnaires to complete. If the patient's global assessment is that they have improved, or if review of their diaries shows an improvement in symptom severity scores (decrease in symptom severity score by > 30% from baseline), they will be eligible for the randomization phase.
Patients, who do not have any improvements during the first 4 weeks of SBI therapy, will not be randomized. If non-responders have worsening of symptoms, they will be prescribed rescue medications as per standard of care. If non-responders choose to continue to take SBI, they will be so allowed.
Randomization Phase: Patients who qualify for this phase will be randomized either to SBI or placebo. They will take their medication for 4 more weeks and complete their questionnaires, symptom as well as QOL. After this 4 week phase all patients will be offered the Open Label Extension Phase.
Open Label Extension Phase: All patients who enter this phase will be treated with SBI for another 16 weeks.
- Being tested
- Serum-Derived Bovine Immunoglobulin, Placebo
- Keywords
- IBS, IBS-D, SBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-Derived Bovine ImmunoglobulinDietary supplement
Also called SBI, Entera
Patients who weigh less than 40 Kg will receive Serum Derived Bovine Immunoglobulin -5 g daily (2.5 g PO BID) and patients who weigh 40 Kg or more will receive Serum Derived Bovine Immunoglobulin- 10 g daily (5 g PO BID)
PlaceboOther
Matching placebo packets will be supplied and will appear identical to SBI with respect to volume, appearance and taste.
Patients who weigh less than 40 Kg will take one-half packet BID (2.5 g BID) Patients who weigh 40 Kg or more will take one packet BID (5 g PO BID).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | Patients who weigh less than 40 Kg will receive 5 g daily (2.5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate Patients who weigh 40 Kg or more will receive 10 g daily (5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate Receives: Dietary Supplement: Serum-Derived Bovine Immunoglobulin |
| Placebo Arm | Placebo comparator | The placebo group will receive a hydrolyzed gelatin protein for next 4 weeks on a daily basis. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The ability of children to take SBI and related side effects
Measured: Intervals from 0 to 4 weeks and from 4 to 8 weeks
Secondary outcomes (1)
Quality of Life Scores
The proportion of subjects who achieve an improvement in their symptoms at the end of different study assessment times.
Measured: Assessed at Day 0, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start15 Jun 2014
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Hyams, MD, Connecticut Children's Medical Center
- Investigators
- Ajay Rana, MD, Principal investigator, Connecticut Childrens Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358694
- Sponsor's protocol ID
- SBI-IBS-D
- Status last verified
- Feb 2019
- First submitted
- 7 Nov 2014
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Serum-Derived Bovine Immunoglobulin in Children With Diarrhea-Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02358694
- Acronym / sponsor ID
- SBI-IBS-D
- Keywords
- IBS, IBS-D, SBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D.
Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.
Detailed description
The study will consist of four phases:
Screening Phase: screen the patients for 2 weeks prior to enrollment in the study to establish objective criteria of disease presence and severity. Patients will maintain a daily symptom dairy. At the end of screening phase, we will calculate their quality of life and symptom severity scores based on the information provided by the patients and their family. Patients with an average score of 1 or greater over 14 days for abdominal pain and stool consistency will be selected for the open label trial of SBI.
Open Label Treatment Phase: patients enrolled will receive 4 weeks of SBI along with QOL questionnaires to complete. If the patient's global assessment is that they have improved, or if review of their diaries shows an improvement in symptom severity scores (decrease in symptom severity score by > 30% from baseline), they will be eligible for the randomization phase.
Patients, who do not have any improvements during the first 4 weeks of SBI therapy, will not be randomized. If non-responders have worsening of symptoms, they will be prescribed rescue medications as per standard of care. If non-responders choose to continue to take SBI, they will be so allowed.
Randomization Phase: Patients who qualify for this phase will be randomized either to SBI or placebo. They will take their medication for 4 more weeks and complete their questionnaires, symptom as well as QOL. After this 4 week phase all patients will be offered the Open Label Extension Phase.
Open Label Extension Phase: All patients who enter this phase will be treated with SBI for another 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Dietary Supplement: Serum-Derived Bovine ImmunoglobulinPatients who weigh less than 40 Kg will receive 5 g daily (2.5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate Patients who weigh 40 Kg or more will receive 10 g daily (5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate |
| Placebo Arm | Placebo comparator | Other: PlaceboThe placebo group will receive a hydrolyzed gelatin protein for next 4 weeks on a daily basis. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female patients > 8 years of age and < 18 years of age
- Patients with a diagnosis of IBS-D as per Rome III criteria
- Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
- Patients with normal fecal calprotectin and lactose hydrogen breath test
- Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
Key exclusion criteria (8 listed)
- Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
- Patients with family history of inflammatory bowel disease
- Patients with history of abdominal surgery
- Patient with history of drug or alcohol abuse
- Patient with a history of allergy to study related products (e.g. beef)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum-Derived Bovine ImmunoglobulinAlso: SBI, EnteraPatients who weigh less than 40 Kg will receive Serum Derived Bovine Immunoglobulin -5 g daily (2.5 g PO BID) and patients who weigh 40 Kg or more will receive Serum Derived Bovine Immunoglobulin- 10 g daily (5 g PO BID) | Dietary supplement | Active Treatment Group |
| PlaceboMatching placebo packets will be supplied and will appear identical to SBI with respect to volume, appearance and taste. Patients who weigh less than 40 Kg will take one-half packet BID (2.5 g BID) Patients who weigh 40 Kg or more will take one packet BID (5 g PO BID). | Other | Placebo Arm |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Intervals from 0 to 4 weeks and from 4 to 8 weeks
The ability of children to take SBI and related side effects
1 secondary outcome
Quality of Life Scores
Time frame: Assessed at Day 0, 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Rana, MD principal investigator
Connecticut Childrens Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum-Derived Bovine Immunoglobulin in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Connecticut Children's Medical Center at 1 site in United States.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 18 Feb 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Intervals from 0 to 4 weeks and from 4 to 8 weeks). 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 18 Feb 2019.