Evidence map›Paper›PMID 9895380›Full record

Trial reportGut1999

Bovine immunoglobulin concentrate-clostridium difficile retains C difficile toxin neutralising activity after passage through the human stomach and small intestine.

M Warny, A Fatimi, E F Bostwick, D C Laine, F Lebel, J T LaMont, C Pothoulakis, C P Kelly

Open access · bronzeAbstract readClinical TrialClinical Trial, Phase I
In one paragraph

Trial report in Gut, 1999. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 119 citations in OpenAlex.

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  3. EnterotoxigenicEClinicalMedicine · 2026
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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

8 authors at 2 institutions in 1 country.

M WarnyGastroenterology Division, Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, Massachusetts 02215, USA.
A Fatimi
E F Bostwick
D C Laine
F Lebel
J T LaMont
C Pothoulakis
C P Kelly
Beth Israel Deaconess Medical Center · USHarvard University · US

Funding

ZINC STATUS AND T CELL DISORDER IN MILD HUMAN ZINC DEFICIENCYM01RR001032 · NCRR · BETH ISRAEL DEACONESS MEDICAL CENTER · PI MANTZOROS, CHRISTOS S · 1985 to 2008
$32.3M
NCRR NIH HHS RR01032
6 · The paper itself

Abstract

backgroundBovine immunoglobulin concentrate (BIC)-Clostridium difficile is prepared from the colostrum of cows immunised against C difficile toxins and contains high concentrations of neutralising IgG antitoxin.

aimsTo determine the proportion of BIC-C difficile which survives passage through the human stomach and small intestine.

methodsSix volunteers with an end ileostomy took 5 g of BIC-C difficile containing 2.1 g of bovine IgG on four occasions: alone, with an antacid, during treatment with omeprazole, and within enteric coated capsules.

resultsWhen BIC-C difficile was taken alone, a mean (SEM) of 1033 (232) mg of bovine IgG was recovered in the ileal fluid representing 49% of the total ingested dose. Bovine IgG recovery was not significantly increased by antacid (636 (129) mg) or omeprazole (1052 (268) mg). The enteric capsules frequently remained intact or only partially opened in the ileal effluent and free bovine IgG levels were low in this treatment group (89 (101) mg). Bovine IgG recovery was higher in volunteers with shorter (less than two hours) mouth to ileum transit times (68% versus 36%, p<0. 05). Specific bovine IgG against C difficile toxin A was detected in ileal fluid following oral BIC. Toxin neutralising activity was also present and correlated closely with bovine IgG levels (r=0.95, p<0. 001).

conclusionBIC-C difficile resists digestion in the human upper gastrointestinal tract and specific anti-C difficile toxin A binding and neutralising activity was retained. Passive oral immunotherapy with anti-C difficile BIC may be a useful non-antibiotic approach to the prevention and treatment of C difficile antibiotic associated diarrhoea and colitis.

Indexed as

Administration, OralAdultAgedAnimalsAntibodies, BacterialAntitoxinsBacterial ToxinsCattleClostridioides difficileColostrumDigestive SystemEnterotoxinsFemaleGastric MucosaGastrointestinal TransitHumansAntibodies, BacterialAntitoxinsBacterial ToxinsEnterotoxinsImmunoglobulin GtcdA protein, Clostridium difficile

Identifiers

PMID9895380
PMCPMC1727384
OpenAlexW2086424425

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.