Clinical trial NCT02163213: Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Keywords: diarrhea
irritable bowel syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This is an open label study evaluating the impact of SBI 5.0 g twice daily on

1. nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),
2. intestinal permeability (in vivo) and
3. 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,

Eligibility criteria: Inclusion criteria:

1. Age 18-65y
2. Male or non-pregnant female
3. IBS by Rome III criteria with predominant symptom of diarrhea
4. Baseline 14 day diary showing average of 2 days per week with \>3 bowel movements per day

Exclusion criteria:

1. Intake of medications that interfere with the study
2. Antibiotic within prior 2 weeks and throughout study
3. Prior abdominal surgery except appendectomy
4. Active gastrointestinal diagnosis other than IBS
5. History of allergy or intolerance to beef or to any ingredient in the investigational product
6. Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
7. 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)
8. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
9. 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.

Primary outcomes:
measure: Change in epithelial barrier function, and mucosal expression of barrier-associated genes
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.
timeFrame: 10 weeks
Other outcomes:
measure: Duodenal and fecal microbiomes
timeFrame: 10 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.