Evidence map›Paper›PMID 37248499›Full record

ArticleTrials2023

The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery - study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial.

Shámila Ismael, Carlos Vaz, Catarina Durão, Marta P Silvestre, Conceição Calhau, Diana Teixeira, Cláudia Marques

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05170867 (The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 31% 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.

NCT05170867 nacompletednot on this map

The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial

TypeinterventionalSponsorUniversidade Nova de LisboaRan2022 to 2025Enrolled49ConditionsObesity, Type 2 DiabetesArmsHafnia alvei HA4597™, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. The impact of probiotics on glycemic control during the first 3 months after sleeve gastrectomy: a prospective placebo‑controlled study.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2025
    Article
  3. 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

7 authors at 2 institutions in 1 country.

Shámila IsmaelNutrition & Metabolism, CHRC, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal.
Carlos VazObesity and Metabolic Surgery Unit, Hospital CUF Tejo, Lisbon, Portugal.
Catarina DurãoObesity and Metabolic Surgery Unit, Hospital CUF Tejo, Lisbon, Portugal.
Marta P SilvestreNutition & Metabolism, CINTESIS@RISE, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal.
Conceição CalhauNutition & Metabolism, CINTESIS@RISE, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal.
Diana Teixeira *Nutrition & Metabolism, CHRC, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal. diana.teixeira@nms.unl.pt.
Cláudia Marques *Nutition & Metabolism, CINTESIS@RISE, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal. claudia.sofia.marques@nms.unl.pt.
Universidade Nova de Lisboa · PTCUF Porto Hospital · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubjects with obesity exhibit changes in gut microbiota composition and function (i.e. dysbiosis) that contribute to metabolic dysfunction, including appetite impairment. Although bariatric surgery is an effective treatment for obesity with a great impact on weight loss, some subjects show weight regain due to increased energy intake after the surgery. This surgery involves gut microbiota changes that promote appetite control, but it seems insufficient to completely restore the obesity-associated dysbiosis - a possible contributor for weight regain. Thus, modulating gut microbiota with probiotics that could improve appetite regulation as a complementary approach to post-operative diet (i.e. Hafnia alvei HA4597™), may accentuate post-surgery weight loss and insulin sensitivity.

methodsThis is a protocol of a triple-blinded, blocked-randomized, parallel-group, placebo-controlled clinical trial designed to determine the effect of Hafnia alvei HA4597™ supplementation on weight loss and glycaemic control 1 year after bariatric surgery. Patients of Hospital CUF Tejo, Lisbon, that undergo Roux-en-Y gastric bypass are invited to participate in this study. Men and women between 18 and 65 years old, with a BMI ≥ 35 kg/m DISCUSSION: The evidence obtained in this study will provide relevant information regarding the profile of the intestinal microbiota of individuals with severe obesity and the identification of the risk/benefit ratio of the use of Hafnia alvei HA4597™ as an adjunctive treatment in the maintenance of metabolic and weight control one year after the surgical intervention.

trial registrationClinicalTrials.gov NCT05170867. Registered on 28 December 2021.

Indexed as

Bariatric SurgeryGastric BypassHafnia alveiObesity, MorbidAdolescentAdultAgedDysbiosisFemaleGlycemic ControlHumansMaleMiddle AgedObesityQuality of LifeRandomized Controlled Trials as TopicBariatric surgeryGlycaemic controlHafnia alvei HA4597™ObesityWeight loss

Identifiers

PMID37248499
PMCPMC10226263
OpenAlexW4378716988

What OpenQuestion holds

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LicenceCC BY
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.