Evidence map›Paper›PMID 15918198›Full record

Trial reportWorld journal of gastroenterology2005

Oral immune regulation using colitis extracted proteins for treatment of Crohn's disease: results of a phase I clinical trial.

Eran Israeli, Eran Goldin, Oren Shibolet, Athalia Klein, Nilla Hemed, Dean Engelhardt, Elazar Rabbani, Yaron Ilan

Abstract readClinical TrialClinical Trial, Phase I
In one paragraph

Trial report in World journal of gastroenterology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
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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.

Eran IsraeliGastroenterology Unit, Department of Medicine, Hebrew University-Hadassah Medical Center, Jerusalem, Israel.
Eran Goldin
Oren Shibolet
Athalia Klein
Nilla Hemed
Dean Engelhardt
Elazar Rabbani
Yaron Ilan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate safety and possible efficacy of induction of oral immune regulation using colitis extracted proteins (CEP) in Crohn's disease (CD) subjects.

methodsTen CDs were treated orally with autologous CEP thrice weekly for 16 wk. Subjects were monitored for CDAI and IBDQ. Immune modulatory effect was assessed by T-lymphocyte FACS analysis, CEP-specific IFNgamma ELISPOT assay and cytokine levels.

resultsInduction of oral immune regulation significantly ameliorated disease activity. All (10/10) subjects had clinical response (CDAI < or = 70) and 7/10 achieved clinical remission (CDAI < or = 150). Significant increase in mean IBDQ score was noted (134+/-9 vs 164+/-12). No treatment-related adverse events were noted. High levels of CEP-specific IFNgamma spot forming colonies were detected in five subjects prior to treatment and in all five, a marked decrease was observed. The CD4+/CD8+ lymphocyte ratio and peripheral NKT cell numbers increased significantly, in 7/10 and in 5/10 subjects, respectively. Significant increase in serum IL-10 and IL-4 levels was observed in 7/10 subjects during treatment period.

conclusionImmune regulation via oral administration of CEP is a safe and possibly effective treatment for subjects with moderate CD and may provide means of antigen-specific immune modulation.

Indexed as

Administration, OralAdultColonCrohn DiseaseFemaleHumansIntestinal MucosaMaleMiddle AgedProspective StudiesProteinsProteins

Identifiers

PMID15918198
PMCPMC4305848

What OpenQuestion holds

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Registered trials

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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.