Functional ConstipationBifidoDigestNCT04231162
Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation
A study testing Active product in people with Functional Constipation, run by Danisco at 4 sites in France.
Trial summary
This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Active product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Sep 2020to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free-living females and males of age 18 to 70 years (limits included),
- Body mass index between 18.5 and 34.9 kg/m² (limits included),
- Meets the ROME III criteria for functional constipation as follows (criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Must meet 2 or more of the following criteria : i. Straining during at least 25% of defecations, ii. Lumpy or hard stools in at least 25% of defecations, iii. Sensation of incomplete evacuation for at least 25% of defecations, iv. Sensation of anorectal obstruction/blockage for at least 25% of defecations, v. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvis floor), vi. Fewer than three defecations per week, b. Loose stools are rarely present without the use of laxatives, c. Insufficient criteria for Irritable Bowel Syndrome (IBS),
- Self-reported bowel movement frequency up to 3 stools per week for at least the last 6 months,
- Participants who agree to maintain their usual level of activity throughout the trial period,
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- Participants who agree to maintain their usual dietary habits and level of exercise etc; i.e. maintain their usual life-style throughout the trial period,
- Participants who agree not to consume probiotics (except for investigational products), prebiotics, symbiotic, fermented milk, and/or yogurt throughout the trial period,
- Females of child-bearing potential who agree to use medically approved methods for birth control those including condoms with spermicides, hormonal contraceptives (estrogen and/or progestin products; either oral, intrauterine or epidermal) or intrauterine device with copper. The contraceptive method should have been in place for at least 3 cycles before the beginning of the study, and should not be modified during the study. Postmenopausal women with or without hormone replacement therapy who have been applying the estrogenic or estrogenic/progestin treatment for at least 3 months before the beginning of the study and who agree not to change the treatment during the study,
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects,
- Consent to participate in the study and willing to comply with the protocol and study restrictions,
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to research involving the human person,
- Participants who agree to be registered on the national file of the volunteers participating in biomedical research.
- Hematological, serum and urine parameters within the normal ranges, or not clinically-relevant. Nonpregnant females, as indicated by negative pregnancy test,
- 0 to 3 Complete Spontaneous Bowel Movements (CSBM) over the 7 days, per daily diary log between Visit 1 and Visit 2 (Day-15 to Day-9),
- 100% compliance with placebo consumption over the 7 days, per daily diary log between Visit 1 and Visit 2 (Day-15 to Day-9)
- 100% completion of daily diary over the 7 days, per daily diary log between Visit 1 and Visit 2 (Day-15 to Day-9).
- 0 to 3 CSBMs over the 7 days, per daily diary log between Visit 2 and Visit 3 (Day-7 to Day-1),
- 100% compliance with placebo consumption over the 7 days, per daily diary log between Visit 2 and Visit 3 (Day-7 to Day-1)
- 100% completion of daily diary over the 7 days, per daily diary log between Visit 2 and Visit 3 (Day-7 to Day-1).
Who cannot join
- Having hypersensitivity or history of allergy to one of the study products,
- Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator,
- Major gastrointestinal complication (e.g. Crohn's disease, ulcer, IBS-Mixed, IBS-constipation, IBS-Diarrhea, Celiac disease),
- Lactose-intolerants who consume non-lactose-free dairy products. e.g. regular milk, ice-cream. i.e. Lactose-intolerants who cannot manage their condition (those who manage their intolerance, i.e. who don't consume any product which contain lactose, could be included in the study).
- Prior abdominal surgery (e.g. gastric by-pass, gastrectomy, gastric band, visceral surgery…) that, in the opinion of the investigator, may present a risk for the participant or confound study results,
- Current pharmacological treatment related to constipation (e.g., prosecretory agents, antibiotics, antidepressants, antispasmodics, enterokinetic), dietary treatment of constipation (e.g. probiotics, prebiotics, symbiotic, herbal extracts, fibers), or other constipation treatments (e.g. cognitive behavior therapy, acupuncture, biofeedback) or within 1 month before screening,
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- Laxative/suppository use (≥1/month) or laxative/suppository use within 48 hours of screening (rescue medications - e.g., laxatives, suppositories and rescue procedures- e.g., enemas, allowed for intolerable symptoms during study),
- Daily consumption of probiotics, prebiotics, symbiotic, fermented milk, and/or yogurt containing probiotics within 2 weeks prior to screening,
- Use of any drug or dietary supplement during at least 7 consecutive days known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminium, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month before screening,
- Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness),
- Systemic steroid use within 1 month before screening,
- Eating disorder (e.g., anorexia, bulimia, etc.),
- Having a lifestyle deemed incompatible with the study according to the investigator e.g., specific diet (vegetarian, vegan, hypocaloric), intense physical activity > 10 hours / week, etc,
- Self-declare history of alcohol abuse (for females: >3 drinks on any single day and >7 drinks per week; for males: >4 drinks on any single day and >14 drinks per week),
- Self-declare use of illicit drugs,
- Pregnant or lactating female, or pregnancy planned during study period,
- Planning to travel for a long time during the study duration or not able to be contacted for emergency reason during the study,
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study,
- Presenting a psychological or linguistic incapacity to understand and sign the informed consent,
- Participating in another clinical trial or in exclusion period from a previous clinical trial,
- Participants under administrative or legal supervision,
- Participants who would receive more than 4500 euros as indemnities for their participation in clinical trial within the 12 last months, including the indemnities for the present study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CEN
Dijon, 21000
Eurofins Optimed
Gières, 38610
Institut Pasteur de Lille
Lille, 59019
Biofortis
Saint-Herblain, 44800
About this study
Official title: Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation: A Double-blind, Randomized; Placebo-controlled Trial
This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation according to ROME III criteria. The hypothesis is that Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of stool frequency of at least 1 stool per week.
- Conditions
- Functional Constipation
- Being tested
- Active product, Control product
- Keywords
- Stool frequency, Probiotic, Lactic bacteria, Bifidobacteria, Transit, Quality of life, Constipation symptoms, Diet supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active productDietary supplement
Bifidobacterium lactis HN019 (probiotic powder). One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
Control productDietary supplement
Placebo. One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
| Study group | Role | What they receive |
|---|---|---|
| probiotic powder, Bifidobacterium lactis | Experimental | Not described Receives: Dietary Supplement: Active product |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of stool frequency
Complete Spontaneous Bowel movement / week (reported in daily diaries)
Measured: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Secondary outcomes (7)
Stool consistency
For each stool by using the Bristol Stool Scale. classify the form of human faeces into seven categories: ypes 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 tending towards diarrhoea, and 6 and 7 indicate diarrhoea
Measured: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Degree of straining
For each stool by using Visual analogue scale, a 100 mm long horizontal VAS, anchored at 0 mm (not at all), 25 mm (a little bit), 50 mm (a moderate amount), 75 mm (a great deal) and 100 mm (an extreme amount).
Measured: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day 1 to Day 28 and Day 30 to D57)
Abdominal pain severity
For each stool by using Visual analogue scale, rated using a 100 mm long horizontal VAS, anchored at 0 mm (none), 25 mm (mild), 50 mm (moderate), 75 mm (severe) and 100 mm (very severe).
Measured: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Bloating severity
For each stool by using Visual analogue scale, rated using a 100 mm long horizontal VAS, anchored at 0 mm (none), 25 mm (mild), 50 mm (moderate), 75 mm (severe) and 100 mm (very severe).
Measured: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Constipation symptoms assessment by the participant
Patient Assessment of Constipation SYMptoms (PAC-SYM) questionnaire: global score, abdominal symptoms, rectal symptoms and symptoms associated to stool, measures the severity of constipation symptoms over the past 2 weeks; no symptom, 0; mild, 1;moderate, 2. severe, 3; very severe, 4
Measured: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Quality of life related to constipation assessment by the participant
Patient Assessment Constipation Quality Of Life (PAC-QOL) 28-question survey. The questions are comprised of four subscales (worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction) and an overall scale. Not at all, 0; A little bit, 1; Moderately, 2; Quite a bit, 3; Extremely, 4
Measured: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Use of rescue medication
Need and use of rescue medication (laxative) during the study (reported in daily diaries)
Measured: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start16 Sep 2020
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Isabelle Metreau, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231162
- Sponsor's protocol ID
- NH-03643 (PEC18369)
- Other IDs
- 2019-A00720-57
- Acronym
- BifidoDigest
- Status last verified
- Feb 2022
- First submitted
- 8 Jan 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ala-Jaakkola R, Forssten SD, Cheng J, Griffon F, Metreau I, Sturm Y, Lecerf JM, Donazzolo Y, Junnila J, Nordlund A, Hibberd A, Ouwehand AC, Ibarra A. Effect of an 8-Week Bifidobacterium lactis HN019 Supplementation on Functional Constipation: A Multi-Center, Triple-Blind, Randomized, Placebo-Controlled Trial. Mol Nutr Food Res. 2025 Sep;69(17):e70081. doi: 10.1002/mnfr.70081. Epub 2025 May 5.
PubMed 40320938
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation: A Double-blind, Randomized; Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04231162
- Acronym / sponsor ID
- BifidoDigest / NH-03643 (PEC18369)
- Conditions
- Functional Constipation
- Keywords
- Stool frequency, Probiotic, Lactic bacteria, Bifidobacteria, Transit, Quality of life, Constipation symptoms, Diet supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation according to ROME III criteria. The hypothesis is that Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of stool frequency of at least 1 stool per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic powder, Bifidobacterium lactis | Experimental | Dietary Supplement: Active product |
| Placebo | Placebo comparator | Dietary Supplement: Control product |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Free-living females and males of age 18 to 70 years (limits included),
- Body mass index between 18.5 and 34.9 kg/m² (limits included),
- Meets the ROME III criteria for functional constipation as follows (criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Self-reported bowel movement frequency up to 3 stools per week for at least the last 6 months,
- Participants who agree to maintain their usual level of activity throughout the trial period,
Key exclusion criteria (22 listed)
- Having hypersensitivity or history of allergy to one of the study products,
- Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator,
- Major gastrointestinal complication (e.g. Crohn's disease, ulcer, IBS-Mixed, IBS-constipation, IBS-Diarrhea, Celiac disease),
- Lactose-intolerants who consume non-lactose-free dairy products. e.g. regular milk, ice-cream. i.e. Lactose-intolerants who cannot manage their condition (those who manage their intolerance, i.e. who don't consume any product which contain lactose, could be included in the study).
- Prior abdominal surgery (e.g. gastric by-pass, gastrectomy, gastric band, visceral surgery…) that, in the opinion of the investigator, may present a risk for the participant or confound study results,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active productBifidobacterium lactis HN019 (probiotic powder). One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time. | Dietary supplement | probiotic powder, Bifidobacterium lactis |
| Control productPlacebo. One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time. | Dietary supplement | Placebo |
Primary outcome
Change from baseline of stool frequency
Time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Complete Spontaneous Bowel movement / week (reported in daily diaries)
7 secondary outcomes
Stool consistency
Time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Degree of straining
Time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day 1 to Day 28 and Day 30 to D57)
Abdominal pain severity
Time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Bloating severity
Time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)
Constipation symptoms assessment by the participant
Time frame: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Quality of life related to constipation assessment by the participant
Time frame: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Use of rescue medication
Time frame: Day 0 (baseline, Visit 3), Day 29 (Visit 4, 4 weeks) and Day 58 (Visit 5, 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 40320938Ala-Jaakkola R, Forssten SD, Cheng J, Griffon F, Metreau I, Sturm Y, Lecerf JM, Donazzolo Y, Junnila J, Nordlund A, Hibberd A, Ouwehand AC, Ibarra A. Effect of an 8-Week Bifidobacterium lactis HN019 Supplementation on Functional Constipation: A Multi-Center, Triple-Blind, Randomized, Placebo-Controlled Trial. Mol Nutr Food Res. 2025 Sep;69(17):e70081. doi: 10.1002/mnfr.70081. Epub 2025 May 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Metreau, MD principal investigator
BioFortis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active product in people with Functional Constipation, run by Danisco at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of stool frequency (time frame: Baseline (Day-15 to Day-9 and Day-7 to Day-1) and Intervention (Day1 to Day28 and Day30 to Day57)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.