Evidence map›Paper›PMID 27612653›Full record

Trial reportNutrition journal2016

Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial.

Lina Östlund-Lagerström, Annica Kihlgren, Dirk Repsilber, Bengt Björkstén, Robert J Brummer, Ida Schoultz

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01837940 (Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population), which is not on this map. Cited by 29 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 6 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT01837940 phase3completednot on this map

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population

TypeinterventionalSponsorÖrebro University, SwedenRan2013 to 2013Enrolled290ConditionsConstipation, Diarrhea, Indigestion, RefluxArmsPlacebo, Lactobacillus reuteri DSM 17938
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 6 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
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  7. Trial
  8. Bacillus Subtilis (BG01-4Nutrients · 2023
    Trial
  9. Trial
  10. Article
  11. Review
  12. Review
  13. Recent advances in drug delivery and formulation · 2024
    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

6 authors at 1 institution in 1 country.

Lina Östlund-LagerströmNutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden.
Annica KihlgrenNutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden.
Dirk RepsilberNutrition Gut Brain Interactions Research Centre, School of Health and Medical Sciences, Faculty of Health and Medicine, Örebro University, Örebro, Sweden.
Bengt BjörksténNutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden.
Robert J BrummerNutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden.
Ida SchoultzNutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden. ida.schoultz@oru.se.ORCID 0000-0002-8391-1576
Örebro University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiseases of the digestive system have been found to contribute to a higher symptom burden in older adults. Thus, therapeutic strategies able to treat gastrointestinal discomfort might impact the overall health status and help older adults to increase their overall health status and optimal functionality.

objectiveThe aim of this double-blinded, randomized, placebo-controlled clinical trial was to evaluate the effect of the probiotic strain Lactobacillus reuteri on digestive health and wellbeing in older adults.

methodsThe study enrolled general older adults (>65 years). After eligibility screening qualified subjects (n = 290) participated in a 2-arm study design, with each arm consisting of 12 weeks of intervention of either active or placebo product. Primary outcome measure was set to changes in gastrointestinal symptoms and secondary outcome measures were changes in level of wellbeing, anxiety and stress. Follow up was performed at 8 and 12 weeks.

resultsNo persistent significant effects were observed on the primary or secondary outcome parameters of the study. A modest effect was observed in the probiotic arm, were levels of stress decreased at week 8 and 12. Similarly, we found that subjects suffering from indigestion and abdominal pain, respectively, showed a significant decrease of anxiety at week 8 after probiotic treatment, but not at week 12.

conclusionThe RCT failed to show any improvement in digestive health after daily intake of a probiotic supplement containing L. reuteri. Neither was any significant improvement in wellbeing, stress or anxiety observed. Even though the RCT had a negative outcome, the study highlights issues important to take into consideration when designing trials among older adults.

trial registrationClinicaltrials.gov/ NCT01837940 .

Indexed as

Limosilactobacillus reuteriAbdominal PainAgedAnxietyDepressionDouble-Blind MethodDyspepsiaFemaleHumansMalePatient ComplianceProbioticsSocioeconomic FactorsStress, PsychologicalTreatment OutcomeDigestive healthLactobacillus reuteriOlder adultsProbioticsWellbeing

Identifiers

PMID27612653
PMCPMC5018181
OpenAlexW2512056164

What OpenQuestion holds

Textmetadata
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.