Evidence map›Paper›PMID 23660579›Full record

Trial reportAIDS (London, England)2013

Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy.

David M Asmuth, Zhong-Min Ma, Anthony Albanese, Netanya G Sandler, Sridevi Devaraj, Thomas H Knight, Neil M Flynn, Tammy Yotter, Juan-Carlos Garcia, Emily Tsuchida and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in AIDS (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01313910 early_phase1completednot on this map

CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

TypeinterventionalSponsorUniversity of California, DavisRan2011 to 2012Enrolled8ConditionsHIVArmsImmunolin®
NCT02609529 nacompletednot on this mapstarted 2015, after this paper: background citation

Double-Blind, Randomized Pilot Study Evaluating Oral Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) on Nutritional Status in Children With Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)

TypeinterventionalSponsorLouisiana State University Health Sciences Center in New OrleansRan2015 to 2017Enrolled20ConditionsIrritable Bowel SyndromeArmsMedical Food, Placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

David M AsmuthaUniversity of California Davis Medical School bVeterans Administration Northern California Healthcare System, Sacramento cUniversity of California - Davis dCenter for Comparative Medicine, Davis, California eVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland fBaylor College of Medicine and Texas Children's Hospital, Houston, Texas gCARES Clinic, Sacramento, California hMayo Clinic, Rochester, Minnesota, USA.
Zhong-Min Ma
Anthony Albanese
Netanya G Sandler
Sridevi Devaraj
Thomas H Knight
Neil M Flynn
Tammy Yotter
Juan-Carlos Garcia
Emily Tsuchida
Tsung-Teh Wu
Daniel C Douek
Christopher J Miller
University of California Davis Medical Center · USNational Institute of Allergy and Infectious Diseases · USVA Northern California Health Care System · USGTx (United States) · USMayo Clinic · USTexas Children's Hospital · USUniversity of California, Davis · US

Funding

National Institute on Aging (NIA) ColonyP51OD011107 · OD · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Simon J. Atkinson · 2012 to 2026
$191.5M
UC DAVIS CLINICAL AND TRANSLATIONAL SCIENCE CENTER: BPCAUL1RR024146 · NCRR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2006 to 2011
$27.0M
Using Technology to Enhance Cancer Communication and Improve Clinical OutcomesP50CA095817 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI GUSTAFSON, DAVID H · 2003 to 2012
$19.3M
NCI NIH HHS P50 CA095817NCRR NIH HHS UL1 RR024146NIH HHS P51 OD011107
6 · The paper itself

Abstract

objectivesTo examine the impact of serum-derived bovine immunoglobulin, an oral medical food known to neutralize bacterial antigen and reduce intestinal inflammation, on restoration of mucosal immunity and gastrointestinal function in individuals with HIV enteropathy.

designOpen-label trial with intensive 8-week phase of bovine serum immunoglobulin (SBI) 2.5 g twice daily with a 4-week washout period and an optional 9-month extension study.

methodsHIV enteropathy was defined as chronic gastrointestinal symptoms including frequent loose or watery stools despite no identifiable, reversible cause. Upper endoscopy for tissue immunofluorescent antibody assay and disaccharide gut permeability/absorption studies were performed before and after 8 weeks of SBI to test mucosal immunity and gastrointestinal function. Blood was collected for markers of microbial translocation, inflammation, and collagen kinetics. A validated gastrointestinal questionnaire assessed changes in symptoms.

resultsAll eight participants experienced profound improvement in symptoms with reduced bowel movements/day (P = 0.008) and improvements in stool consistency (P = 0.008). Gut permeability was normal before and after the intervention, but D-xylose absorption increased in seven of eight participants. Mucosal CD4 lymphocyte densities increased by a median of 139.5 cells/mm2 from 213 to 322 cells/mm2 (P = 0.016). Intestinal-fatty acid binding protein (I-FABP), a marker of enterocyte damage, initially rose in seven of eight participants after 8 weeks (P = 0.039), and then fell below baseline in four of five who continued receiving SBI (P = 0.12). Baseline serum I-FABP levels were negatively correlated with subsequent rise in mucosal CD4 lymphocyte densities (r = -0.74, P = 0.046).

conclusionSBI significantly increases intestinal mucosal CD4 lymphocyte counts, improves duodenal function, and showed evidence of promoting intestinal repair in the setting of HIV enteropathy.

Indexed as

AdsorptionImmunity, MucosalAdministration, OralAdultAnimalsCattleCD4 Lymphocyte CountDietDuodenumHIV EnteropathyHumansImmunoglobulinsMalePilot ProjectsSerum GlobulinsTreatment OutcomeImmunoglobulinsSerum Globulins

Identifiers

PMID23660579
PMCPMC3754419
OpenAlexW2051586762

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.