Diarrhea-predominant Irritable Bowel SyndromeNCT02163213
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
A study testing Serum-derived bovine immunoglobulin protein isolate (SBI) in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 2 Nov 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65y
- Male or non-pregnant female
- IBS by Rome III criteria with predominant symptom of diarrhea
- Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
Who cannot join
- Intake of medications that interfere with the study
- Antibiotic within prior 2 weeks and throughout study
- Prior abdominal surgery except appendectomy
- Active gastrointestinal diagnosis other than IBS
- History of allergy or intolerance to beef or to any ingredient in the investigational product
- Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
Show all 9Show fewer
- Use of tobacco products within the past six months or nonsteroidal antiinflammatory drugs or aspirin within the past week (since they all may affect intestinal permeability)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- For two days prior to studies, patients are instructed to avoid ingestion of artificial sweeteners such as Splenda trademark (TM) (sucralose), Nutrasweet TM (aspartame), foods containing lactulose or mannitol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: An Open-Label Study Evaluating the Impact of Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Twice Daily on Nutritional Status in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.
Read the detailed description
This is an open label study evaluating the impact of SBI 5.0 g twice daily on
- nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),
- intestinal permeability (in vivo) and
- mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines status in patients with IBS-D.
Plasma, duodenal and stool samples will be collected. Fifteen eligible subjects will be enrolled to receive SBI for 8 weeks (SBI 5.0g BID for 8 weeks).
Intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral ingestion.
Biopsies from the distal second or third portion of the duodenum will be obtained endoscopically, to measure mRNA expression of tight junction proteins and markers of immune function,
- Being tested
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Keywords
- diarrhea, irritable bowel syndrome
- Medical subject headings
- Diarrhea, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-derived bovine immunoglobulin protein isolate (SBI)Other
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D
| Study group | Role | What they receive |
|---|---|---|
| Serum Bovine Immunoglobulin | Other | Serum-Derived Bovine Immunoglobulin (SBI) 5.0 g by mouth twice daily;
Effects of SBI will be compared with observations and measurements performed at baseline PRIOR to starting the SBI treatment Receives: Other: Serum-derived bovine immunoglobulin protein isolate (SBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in epithelial barrier function, and mucosal expression of barrier-associated genes
The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
Measured: 10 weeks
Secondary outcomes (1)
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.
The secondary endpoints for the study is change from baseline in amino acid metabolism
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion1 Nov 2016
- Study completion2 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163213
- Sponsor's protocol ID
- 14-002151
- Status last verified
- Oct 2017
- First submitted
- 9 Jun 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang XJ, Carlson P, Chedid V, Maselli DB, Taylor AL, McKinzie S, Camilleri M. Differential mRNA Expression in Ileal Mucosal Biopsies of Patients With Diarrhea- or Constipation-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2021 Apr 12;12(4):e00329. doi: 10.14309/ctg.0000000000000329.
PubMed 33843785
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Impact of Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Twice Daily on Nutritional Status in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT02163213
- Acronym / sponsor ID
- 14-002151
- Keywords
- diarrhea, irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 2 Nov 2016 (actual)
- First posted
- 13 Jun 2014 (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.
To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.
Detailed description
This is an open label study evaluating the impact of SBI 5.0 g twice daily on
- nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),
- intestinal permeability (in vivo) and
- mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines status in patients with IBS-D.
Plasma, duodenal and stool samples will be collected. Fifteen eligible subjects will be enrolled to receive SBI for 8 weeks (SBI 5.0g BID for 8 weeks).
Intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral ingestion.
Biopsies from the distal second or third portion of the duodenum will be obtained endoscopically, to measure mRNA expression of tight junction proteins and markers of immune function,
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum Bovine Immunoglobulin | Other | Other: Serum-derived bovine immunoglobulin protein isolate (SBI)Serum-Derived Bovine Immunoglobulin (SBI) 5.0 g by mouth twice daily; Effects of SBI will be compared with observations and measurements performed at baseline PRIOR to starting the SBI treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65y
- Male or non-pregnant female
- IBS by Rome III criteria with predominant symptom of diarrhea
- Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
Key exclusion criteria (9 listed)
- Intake of medications that interfere with the study
- Antibiotic within prior 2 weeks and throughout study
- Prior abdominal surgery except appendectomy
- Active gastrointestinal diagnosis other than IBS
- History of allergy or intolerance to beef or to any ingredient in the investigational product
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 immunoglobulin protein isolate (SBI)Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D | Other | Serum Bovine Immunoglobulin |
Primary outcome
Change in epithelial barrier function, and mucosal expression of barrier-associated genes
Time frame: 10 weeks
The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
1 secondary outcome
Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.
Time frame: 10 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 Oct 2017.
- Derived from this study: PubMed 33843785Wang XJ, Carlson P, Chedid V, Maselli DB, Taylor AL, McKinzie S, Camilleri M. Differential mRNA Expression in Ileal Mucosal Biopsies of Patients With Diarrhea- or Constipation-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2021 Apr 12;12(4):e00329. doi: 10.14309/ctg.0000000000000329.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
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 protein isolate (SBI) in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Mayo Clinic 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 4 inclusion and 9 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 Oct 2017. 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. 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?
Change in epithelial barrier function, and mucosal expression of barrier-associated genes (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163213, which also lists 1 linked publication.
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 Oct 2017.