Evidence map›Paper›PMID 32576228›Full record

ArticleTrials2020

Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial.

Omid Sadeghi, Alireza Milajerdi, Seyed Davar Siadat, Seyed Ali Keshavarz, Ali Reza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Prebiotics for induction and maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Is fruits granola beneficial for blood pressure management?Hypertension research : official journal of the Japanese Society of Hypertension · 2025
    Article
  6. Prevotellaceae Modulates Colorectal Cancer Immune Microenvironment to Assist Anti-PD-L1 Immunotherapy.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2024
    Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. The Lactoferrin Phenomenon-A Miracle Molecule.Molecules (Basel, Switzerland) · 2022
    Review
  12. Nutritional, Phytochemical, andInternational journal of food science · 2022
    Article
  13. Article
  14. Article
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 3 institutions in 1 country.

Omid SadeghiStudents Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Alireza MilajerdiStudents Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Seyed Davar SiadatDepartment of Mycobacteriology and Pulmonary Research, Microbiology Research Center, Pasteur Institute of Iran, Tehran, Iran.
Seyed Ali KeshavarzDepartment of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.
Ali Reza SimaDigestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Homayoon VahediDigestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Peyman AdibiIntegrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Ahmad EsmaillzadehDepartment of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran. a-esmaillzadeh@sina.tums.ac.ir.
Tehran University of Medical Sciences · IRIsfahan University of Medical Sciences · IRPasteur Institute of Iran · IR

Funding

Tehran University of Medical Sciences and Health Services 97-01-161-39471
6 · The paper itself

Abstract

backgroundSeveral strategies are recommended to alleviate clinical symptoms of ulcerative colitis (UC). Soy milk may affect UC through its anti-inflammatory properties. However, no study has examined the effects of soy milk consumption on gut microbiota and inflammatory biomarkers in patients with UC. The current study will be done to examine the effects of soy milk consumption on UC symptoms, inflammation, and gut microbiota in patients with UC.

methodsThis study is a randomized clinical trial, in which thirty patients with mild to moderate severity of UC will be randomly allocated to receive either 250 mL/day soy milk plus routine treatments (n = 15) or only routine treatments (n = 15) for 4 weeks. Assessment of anthropometric measures and biochemical indicators including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interferon gamma (IFN-γ) will be done at the study baseline and end of trial. In addition, the quantity of butyrate-producing bacteria including Clostridium cluster IV, Faecalibacterium prausnitzii, and Roseburia spp.; prebiotic bacteria including Lactobacillus spp. and Bifidobacteria spp.; and mucus-degrading bacteria including Akkermansia muciniphila, Bacteroides fragilis, and Ruminococcus spp., as well as calprotectin and lactoferrin levels, will be explored in fecal samples. Also, the Firmicutes to Bacteroidetes ratio which is of significant relevance in human gut microbiota composition will be assessed. DISCUSSION: Altered gut microbiota has been reported as an important contributing factor to inflammation in patients with inflammatory bowel disease (IBD). Soy milk contains several components such as phytoestrogens with potential anti-inflammatory properties. This product might affect gut microbiota through its protein and fiber content. Therefore, soy milk might beneficially affect systemic inflammation, gut microbiota, and then clinical symptoms in patients with UC.

trial registrationIranian Registry of Clinical Trials (www.irct.ir) IRCT20181205041859N1. Registered on 27 January 2019.

Indexed as

EatingSeverity of Illness IndexAdultAnti-Inflammatory AgentsBiomarkersColitis, UlcerativeFecesFemaleGastrointestinal MicrobiomeHumansInflammationIranMaleMiddle AgedPhytoestrogensQuality of LifeAnti-Inflammatory AgentsBiomarkersPhytoestrogensInflammationMicrobiotaRCTSoy milkUlcerative colitis

Identifiers

PMID32576228
PMCPMC7310397
OpenAlexW3036122083

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.