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Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome.

Wilson D, Evans M, Weaver E, Shaw AL, Klein GL - Clin Med Insights Gastroenterol (2013)

Bottom Line: Subjects who received SBI at 10 g/day (N = 15) had statistically significant within-group reductions in abdominal pain (p < 0.01), loose stools (p < 0.01), bloating (p < 0.05), flatulence (p < 0.01), urgency (p < 0.05) and any symptom (p < 0.01) at EOT vs. baseline.Subjects receiving 5 g/day of SBI (N = 15) realized statistically significant within-group reductions in days with flatulence (p < 0.035), incomplete evacuation (p < 0.05), and any symptom (p < 0.01).This pilot study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in 30 patients was well tolerated and resulted in statistically significant within group improvements in both symptom days and in daily symptom scores in subjects with IBS-D.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine, University of Western Ontario, London, Ontario, Canada.

ABSTRACT

Background: There is increased interest in combining nutritional modalities with pharmacological therapies for managing patients with diarrhea-predominant IBS (IBS-D).

Aim: A randomized, double-blind, placebo-controlled study to evaluate the impact of oral serum-derived bovine immunoglobulin/protein isolate (SBI) on gastrointestinal symptom scores and quality of life (QoL) in subjects with IBS-D.

Methods: Study subjects previously diagnosed with IBS-D according to ROME II criteria were recruited from London, Ontario, Canada and assigned to receive 5 g/day SBI, 10 g/day SBI, or placebo for 6 weeks. Daily symptom frequency and severity scores and a modified IBS-36 questionnaire assessed the impact of nutritional intervention. Laboratory assessments were performed at screening and end of treatment (EOT) to evaluate safety. Within-group comparisons of changes in number of days per week with symptoms and symptom severity were conducted on the per-protocol population of subjects using a t-test.

Results: Subjects who received SBI at 10 g/day (N = 15) had statistically significant within-group reductions in abdominal pain (p < 0.01), loose stools (p < 0.01), bloating (p < 0.05), flatulence (p < 0.01), urgency (p < 0.05) and any symptom (p < 0.01) at EOT vs. baseline. Subjects receiving 5 g/day of SBI (N = 15) realized statistically significant within-group reductions in days with flatulence (p < 0.035), incomplete evacuation (p < 0.05), and any symptom (p < 0.01). There were no significant changes in QoL scores or in hematology or clinical chemistry among treatment groups.

Conclusions: This pilot study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in 30 patients was well tolerated and resulted in statistically significant within group improvements in both symptom days and in daily symptom scores in subjects with IBS-D. Additional studies are underway with larger numbers of subjects to validate these findings.

No MeSH data available.


Related in: MedlinePlus

Subject disposition.
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Related In: Results  -  Collection


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f2-cgast-6-2013-049: Subject disposition.

Mentions: A total of 66 subjects diagnosed with IBS-D were enrolled in the study and underwent randomization: 25 in the 10 g/day SBI group, 19 in the 5 g/day SBI group, and 22 in the placebo group (Fig. 2). All patients who underwent randomization took at least one dose of assigned investigational product.


Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome.

Wilson D, Evans M, Weaver E, Shaw AL, Klein GL - Clin Med Insights Gastroenterol (2013)

Subject disposition.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4020402&req=5

f2-cgast-6-2013-049: Subject disposition.
Mentions: A total of 66 subjects diagnosed with IBS-D were enrolled in the study and underwent randomization: 25 in the 10 g/day SBI group, 19 in the 5 g/day SBI group, and 22 in the placebo group (Fig. 2). All patients who underwent randomization took at least one dose of assigned investigational product.

Bottom Line: Subjects who received SBI at 10 g/day (N = 15) had statistically significant within-group reductions in abdominal pain (p < 0.01), loose stools (p < 0.01), bloating (p < 0.05), flatulence (p < 0.01), urgency (p < 0.05) and any symptom (p < 0.01) at EOT vs. baseline.Subjects receiving 5 g/day of SBI (N = 15) realized statistically significant within-group reductions in days with flatulence (p < 0.035), incomplete evacuation (p < 0.05), and any symptom (p < 0.01).This pilot study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in 30 patients was well tolerated and resulted in statistically significant within group improvements in both symptom days and in daily symptom scores in subjects with IBS-D.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine, University of Western Ontario, London, Ontario, Canada.

ABSTRACT

Background: There is increased interest in combining nutritional modalities with pharmacological therapies for managing patients with diarrhea-predominant IBS (IBS-D).

Aim: A randomized, double-blind, placebo-controlled study to evaluate the impact of oral serum-derived bovine immunoglobulin/protein isolate (SBI) on gastrointestinal symptom scores and quality of life (QoL) in subjects with IBS-D.

Methods: Study subjects previously diagnosed with IBS-D according to ROME II criteria were recruited from London, Ontario, Canada and assigned to receive 5 g/day SBI, 10 g/day SBI, or placebo for 6 weeks. Daily symptom frequency and severity scores and a modified IBS-36 questionnaire assessed the impact of nutritional intervention. Laboratory assessments were performed at screening and end of treatment (EOT) to evaluate safety. Within-group comparisons of changes in number of days per week with symptoms and symptom severity were conducted on the per-protocol population of subjects using a t-test.

Results: Subjects who received SBI at 10 g/day (N = 15) had statistically significant within-group reductions in abdominal pain (p < 0.01), loose stools (p < 0.01), bloating (p < 0.05), flatulence (p < 0.01), urgency (p < 0.05) and any symptom (p < 0.01) at EOT vs. baseline. Subjects receiving 5 g/day of SBI (N = 15) realized statistically significant within-group reductions in days with flatulence (p < 0.035), incomplete evacuation (p < 0.05), and any symptom (p < 0.01). There were no significant changes in QoL scores or in hematology or clinical chemistry among treatment groups.

Conclusions: This pilot study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in 30 patients was well tolerated and resulted in statistically significant within group improvements in both symptom days and in daily symptom scores in subjects with IBS-D. Additional studies are underway with larger numbers of subjects to validate these findings.

No MeSH data available.


Related in: MedlinePlus