Cited by 151Probiotics and Fermented FoodsGastrointestinal motility and disordersGut microbiota and health

Effect of a fermented milk containing Bifidobacterium lactis DN-173010 on Chinese constipated women

Open access
Yang, Yue-Xin, He, Mei, Hu, Gang, Wei, Jie, Pages, Philippe, Yang, Xian-Hua, Bourdu-Naturel, Sophie·2008·World Journal of Gastroenterology

Abstract

AIM: To investigate the effect of a fermented milk containing Bifidobacterium lactis DN-173010 and yogurt strains (BIO(R)) on adult women with constipation in Beijing. METHODS: A total of 135 adult females with constipation were randomly allocated to consume for 2 wk either 100 g of the test fermented milk or 100 g of an acidified milk containing non-living bacteria (control). Stool frequency, defecation condition scores, stool consistency and food intake were recorded at baseline and after 1 and 2 wk in an intention-to-treat population of 126 subjects. In parallel, safety evaluation parameters were performed. RESULTS: At baseline, no differences were found between groups. Following consumption of test product, stool frequency was significantly increased after 1 wk (3.5 +/- 1.5 vs 2.4 +/- 0.6, P < 0.01) and 2 wk (4.1 +/- 1.7 vs 2.4 +/- 0.6, P < 0.01), vs baseline. Similarly, after 1 and 2 wk, of test product consumption, defecation condition (1.1 +/- 0.9 vs 1.9 +/- 1.2, P < 0.01 and 0.8 +/- 1.0 vs 1.9 +/- 1.2, P < 0.01, respectively) and stool consistency (1.0 +/- 0.8 vs 1.5 +/- 1.1, P < 0.01 and 0.6 +/- 0.8 vs 1.5 +/- 1.1, P < 0.01, respectively) were significantly improved. Compared with the control group, stool frequency was also significantly increased (3.5 +/- 1.5 vs 2.5 +/- 0.9, P < 0.01 and 4.1 +/- 1.7 vs 2.6 +/- 1.0, P < 0.01, respectively), and defecation condition (1.1 +/- 0.9 vs 1.6 +/- 1.1, P < 0.01 and 0.8 +/- 1.0 vs 1.6 +/- 1.1, P < 0.01, respectively) and stool consistency (1.0 +/- 0.8 vs 1.4 +/- 1.0, P < 0.05 and 0.6 +/- 0.8 vs 1.3 +/- 1.0, P < 0.01, respectively) significantly decreased after 1 and 2 wk of product consumption. During the same period, food intake did not change between the two groups, and safety parameters of the subjects were within normal ranges. CONCLUSION: This study suggests a beneficial effect of a fermented milk containing B. lactis DN-173010 on stool frequency, defecation condition and stool consistency in adult women with constipation constipated women after 1 and 2 wk of consumption.

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Written from the paper’s full text.

TL;DR

In a randomized 2-week study of 135 constipated women in Beijing (126 analyzed), daily fermented milk containing B. lactis DN-173010 plus yogurt starters improved stool frequency, defecation condition, and stool consistency versus baseline and control. The product was well tolerated, with no adverse effects reported.

Key findings

  • Stool frequency increased in the test group from 2.4 ± 0.6 at baseline to 3.5 ± 1.5 at week 1 and 4.1 ± 1.7 at week 2 (both P < 0.01); versus control, values were 3.5 ± 1.5 vs 2.5 ± 0.9 at week 1 and 4.1 ± 1.7 vs 2.6 ± 1.0 at week 2 (both P < 0.01). Control also increased at week 2 (2.6 ± 1.0 vs 2.4 ± 0.6, P < 0.05).
  • Defecation condition scores improved in the test group from 1.9 ± 1.2 to 1.1 ± 0.9 at week 1 and 0.8 ± 1.0 at week 2 (both P < 0.01); versus control, scores were 1.1 ± 0.9 vs 1.6 ± 1.1 and 0.8 ± 1.0 vs 1.6 ± 1.1 (both P < 0.01).
  • Stool consistency scores decreased in the test group from 1.5 ± 1.1 to 1.0 ± 0.8 at week 1 and 0.6 ± 0.8 at week 2 (both P < 0.01); versus control, scores were 1.0 ± 0.8 vs 1.4 ± 1.0 (P < 0.05) and 0.6 ± 0.8 vs 1.3 ± 1.0 (P < 0.01).
  • No adverse effects were reported; blood, urine, stool, liver, and kidney examinations were normal, and food intake did not differ between groups.

Methods

  • 135 women aged 25–65 with constipation (less than three stools/week, increased stool hardness, non-organic/habitual constipation) were recruited at Beijing Hospital; 4 test and 5 control subjects withdrew, leaving 126 analyzed (63 per group).
  • Subjects were randomly allocated to consume daily for 2 weeks one 100-g pot of either test fermented milk (BIO, containing B. lactis DN-173010 at 1.25 × 10¹⁰ cfu/pot plus S. thermophilus and L. bulgaricus at 1.2 × 10⁹ cfu/pot) or control acidified milk without ferments or probiotics; analysis was intention-to-treat.
  • Stool frequency, defecation condition score, and stool consistency were recorded at baseline and weeks 1–2; dietary intake was assessed by 48-h food records; comparisons used t test, χ² test, and nonparametric rank sum tests in SPSS.

Limitations

  • The paper does not include a formal limitations section; it states that further studies are required to elucidate mechanisms.
  • Evident from the text: the intervention lasted only 2 weeks, the sample was restricted to women aged 25–65 at a single Beijing center, there was no long-term follow-up, and blinding is not described (only randomized allocation and similar product appearance are reported).
  • The control product also showed some improvements (e.g., stool frequency at week 2, defecation score at week 1, stool consistency at week 2), suggesting possible nonspecific effects; no sample-size calculation or mechanistic measures are reported.

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Integrity signals

Registry

Crossref · 10.3748/wjg.14.6237

Cites

34 of 34 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 6 cited sources checked · 0 supported · 0 flagged

  • Findingown data
    § Stool frequency of the subjects

    Compared with control, stool frequency was significantly increased after 2 wk of test product consumption.

    “Compared with control group, stool frequency was also significantly increased after 1 and 2 wk of product consumption”
    Quote in the paperSubstantial claim
  • Findingown data
    § Stool frequency of the subjects

    In the test product group, stool frequency was significantly increased after 2 wk compared with baseline (4.1 ± 1.7 vs 2.4 ± 0.6, P < 0.01).

    “In the test product group, stool frequency was significantly improved after 1 (3.5 ± 1.5 vs 2.4 ± 0.6, P < 0.01) and 2 wk (4.1 ± 1.7 vs 2.4 ± 0.6, P < 0.01), respectively.”
    Quote in the paperSubstantial claim
  • Findingown data
    § Stool frequency of the subjects

    No differences in stool frequency were found after 1 wk of control product consumption.

    “Compared to baseline, stool frequency was significantly increased after 2 wk of control product consumption (2.6 ± 1.0 vs 2.4 ± 0.6, P < 0.05) but no differences were found after 1 wk.”
    Quote in the paperNot a substantial claim
  • Findingown data
    § Defecation condition scores of the subjects

    In the test product group, defecation condition score was significantly improved after 1 wk compared with baseline (1.1 ± 0.9 vs 1.9 ± 1.2, P < 0.01).

    “In the test product group, defecation condition score was significantly improved after 1 (1.1 ± 0.9 vs 1.9 ± 1.2, P < 0.01) and 2 wk (0.8 ± 1.0 vs 1.9 ± 1.2, P < 0.01), respectively.”
    Quote in the paperSubstantial claim
  • Findingown data
    § Defecation condition scores of the subjects

    In the test product group, defecation condition score was significantly improved after 2 wk compared with baseline (0.8 ± 1.0 vs 1.9 ± 1.2, P < 0.01).

    “In the test product group, defecation condition score was significantly improved after 1 (1.1 ± 0.9 vs 1.9 ± 1.2, P < 0.01) and 2 wk (0.8 ± 1.0 vs 1.9 ± 1.2, P < 0.01), respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims. 9
  • Classified as probably not a substantial claim. 7
  • May combine two claims.

    Findingown data
    § General information of the subjects

    Blood, urine, and stool routine assays and liver and kidney function examinations were all in normal range before and after product consumption, with no clinical changes between groups.

    “Results of blood, urine and stool routine assays, and liver and kidney function examinations were all in normal range before and after product consumption, and there were no clinical changes between the two groups.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingnone given
    § DISCUSSION

    Consumption of the fermented product tested in this study was well tolerated by all participants, and no adverse effects were reported.

    “Consumption of the fermented product tested in this study was well tolerated by all the participants, and no adverse effects were reported.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductown data
    § Study protocol

    Eligible constipated women were randomly allocated to consume daily for 2 wk one pot of either the test product or the control product.

    “Thereafter, eligible constipated women were randomly allocated to consume, daily for 2 wk, one pot of either the test product (67 cases) or the control product (68 cases).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductown data
    § General information of the subjects

    At baseline, the test and control groups did not differ significantly in general conditions, age, weight, eating pattern, appetite, eating amount, stool frequency, defecation condition score, or stool consistency.

    “The general conditions of the other 126 subjects in two groups are described in Table 1.A t test was used for age and weight, χ 2 test for eating pattern and amount, and non-parametric rank sum tests for the three defecation parameters, to compare difference between the two groups.There were no significant differences (P > 0.05).”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § Study protocol

    Subjects were stratified by age, daily eating habits, and constipation causes to the extent possible to ensure inter-group comparability.

    “Subjects were stratified by age, daily eating habits, and constipation causes to the extent possible to ensure inter-group comparability, which could possibly have influenced the results.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § Statistical analysis

    All analyses were conducted on the intention-to-treat population, defined as subjects having consumed at least one pot of product.

    “All analysis were conducted on the intention-to-treat (ITT) population, corresponding to subjects having consumed at least one pot of product.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation
    § INTRODUCTION

    Daily consumption of this product increases stool frequency in IBS subjects with the lowest stool frequency (<3 or 4 bowel movements/wk) without changing stool consistency.

    “An increase in stool frequency was also observed in subjects with the lowest stool frequency (< 3 or 4 bowel movements/wk) without any change of stool consistency.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18] Guyonnet D, Chassany O, Ducrotte P, Picard C, Mouret M, Mercier CH, Matuchansky C. Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial. Aliment Pharmacol Ther 2007;26:475-486. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data
    § General information of the subjects

    Four cases in the test group and five cases in the control group were withdrawn from the study.

    “Female volunteers (n = 135) were recruited for the study; four cases in test group and five cases in control group were withdrawn from the study.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation
    § INTRODUCTION

    Daily consumption of fermented milk containing B. lactis DN-173010 with yogurt starters alleviates bloating and improves digestive comfort in IBS constipation-predominant subjects, as assessed by the Functional Digestive Disorders Quality of Life questionnaire.

    “This large scale (267 IBS constipation predominant, Rome II criteria), double-blind, randomized, controlled, parallel group study over 6 wk demonstrated that daily consumption of this product alleviates bloating and improves digestive comfort as assessed by the Functional Digestive Disorders Quality of Life questionnaire.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18] Guyonnet D, Chassany O, Ducrotte P, Picard C, Mouret M, Mercier CH, Matuchansky C. Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial. Aliment Pharmacol Ther 2007;26:475-486. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § INTRODUCTION

    Bifidobacterium lactis DN-173010 survives complete transit through the digestive tract and is recovered live in stools in large quantities relative to the quantity initially ingested.

    “Bifidobacterium lactis DN-173010 survives complete transit through the digestive tract and is recovered live in stools in large quantities relative to the quantity initially ingested [12][13][14] .”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [12][13][14]

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given
    § Innovations and breakthroughs

    It is believed to be the first study to investigate the effect of B. lactis DN-173010 in another ethnic population with a different diet than European populations.

    “It is believed to be the first study to investigate the effect of B. lactis DN-173010 leaded in another ethnic population with a different diet than European populations.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: No clinical study has been carried out on the effect of fermented milk containing B. lactis DN-173010 on constipation in the Beijing/Chinese population.
  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given
    § DISCUSSION

    Findings in previous studies are inconsistent possibly due to lesser statistical power, the use of different probiotic strains and different subject population.

    “Findings in previous studies are inconsistent possibly due to lesser statistical power, the use of different probiotic strains and different subject population.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Study design and conductreasoning
    § DISCUSSION

    Extrinsic lactase was added to control milk samples during manufacturing to prevent diarrhea due to milk intake in the control group, resulting in equal lactose content between test and control products.

    “In order to prevent diarrhea, due to milk intake in the control group, extrinsic lactase was added to control milk samples during the manufacturing process.This resulted in an equal lactose content between the test and control products.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The incidence rate of lactose intolerance reaches 90% in Chinese adults.
    • Rests on an assumption: Lactose in milk can cause intolerance characterized by rugitus, abdominal distension, abdominal pain, even diarrhea as a severe symptom.
  • May combine two claims.

    Interpretationown data
    § DISCUSSION

    In conclusion, the present large-scale study showed a beneficial effect of a fermented milk containing B. lactis DN-173010 on stool frequency and consistency, as well as on defecation conditions of women with constipation.

    “In conclusion, the present large-scale study showed a beneficial effect of a fermented milk containing B. lactis DN-173010 on stool frequency and consistency, as well as on defecation conditions of women with constipation.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationcitation
    § DISCUSSION

    Our finding that probiotics may normalize bowel movements is in line with previous studies.

    “Our finding that probiotics may normalize bowel movements is in line with those in some previous studies [27][28][29][30] .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [27][28][29][30]

      Not checked in the free run.

15 of 15
  • The paper relies on this without support.

    No clinical study has been carried out on the effect of fermented milk containing B. lactis DN-173010 on constipation in the Beijing/Chinese population.

    “An epidemiological study conducted in Beijing concluded that 6.1% of the adult population was suffering from the symptoms of functional constipation but no clinical study has been carried out in this population.”
  • The paper relies on this without support.

    The incidence rate of lactose intolerance reaches 90% in Chinese adults.

    “The incidence rate of lactose intolerance reaches 90% in Chinese adults.”
  • The paper relies on this without support.

    Lactose in milk can cause intolerance characterized by rugitus, abdominal distension, abdominal pain, even diarrhea as a severe symptom.

    “Lactose in milk can cause intolerance characterized by rugitus, abdominal distension, abdominal pain, even diarrhea as a severe symptom.”
3 of 3

Claims other papers make about this one

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Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Intermediate dietary assessment has conflicting dates

    Minor

    The methods place the intermediate dietary assessment on days 7-8, whereas the results place it on days 6-7.

1 of 1

Cites

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Research works printed but not linked: 1

  1. Guo XK, Pan MY, Han G, Fang S, Lu XC, Guo H. A cluster, stratified, randomized epidemiologic survey and analysis of related factors on adult chronic constipation in Beijing area. Chin J Dig Dis 2002;22:637-638.

Cited by

Sorted by citations

Authors
Yang, Y.-X., He, M., Hu, G., Wei, J., Pages, P., Yang, X.-H., & Bourdu-Naturel, S.
Affiliations
  • Harvard University (US)
  • Beijing Hospital (CN)
  • Danone (France) (FR)
Venue
World Journal of Gastroenterology
Published
2008
Volume
14
Issue
40
Pages
6237
ISSN
1007-9327 (ISSN-L)
OpenAlex
W2004410282
Cited by
151
References
34
Citations by year
2026: 4 · 2025: 7 · 2024: 8 · 2023: 10 · 2022: 9 · 2021: 10 · 2020: 13 · 2019: 15 · 2018: 4 · 2017: 7 · 2016: 4 · 2015: 8 · 2014: 16 · 2013: 8 · 2012: 4
FWCI
12.82
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • World Journal of Gastroenterology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
Keywords
constipation, women, stool frequency, stool consistency, probiotics, acidified milk, functional foods, food safety, fecal microbiota, fecal water content, fecal pH, fecal volatile fatty acids, fecal short-chain fatty acids
MeSH terms
Adult, Aged, Bifidobacterium, China, Constipation, Defecation, Eating, Female, Humans, Middle Aged, Time Factors, Yogurt, Treatment Outcome, Probiotics, Asian People

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