Postpartum DepressionNCT06651424
Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression
A study testing Combination of Lactobacillus probiotics (no comercial) in people with Postpartum Depression, run by Biosearch S.A. at 3 sites in Spain.
Trial summary
The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Combination of Lactobacillus probiotics (no comercial)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jul 2022to 1 Jul 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant who is between 28-32 weeks of gestation.
- Normal development of pregnancy.
- Singleton pregnancy.
- Score ≥12 scale Postpartum depression questionnaire Edinburgh.
- Pregnant who has the firm intention of breastfeeding her child for at least the first month.
- Sign the Informed Consent.
Who cannot join
- Have any breast pathology that makes it difficult or impossible to breastfeed.
- Consume other probiotic supplements during the study.
- History of serious mental disorders other than affective disorders, whether or not currently under pharmacological treatment.
- Low expectation of adherence to the study protocol.
- Pharmacological treatment incompatible with the study.
- Non-compliance with the study protocol.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario del Sureste (Arganda del Rey, Madrid)
Arganda, Madrid, 28500
Clínica Luna de Brigantía (Vigo, Pontevedra)
Vigo, Pontevedra, 36204
Centro de Salud Villacañas de Toledo
Villacañas, Toledo, 45860
About this study
Official title: Multicenter, Randomized, Double-blind, Parallel-group Controlled Nutritional Intervention Study to Evaluate the Effect of a Combination of Probiotic Strain on Postpartum Depression
The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
Read the detailed description
The mood disorders such as postpartum depression have a very high incidence. There is a relationship between a woman's microbiota and the risk of postpartum depression.
The possibility of influencing the microbiota through probiotic treatments opens a door to the prevention and/or treatment of postpartum depression.
Therefore, the objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
- Conditions
- Postpartum Depression
- Being tested
- Combination of Lactobacillus probiotics (no comercial), Placebo
- Keywords
- Probiotics, Depression, Postpartum
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Lactobacillus probiotics (no comercial)Dietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
PlaceboDietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Pregnants will take 1 capsule with a combination of probiotics (no comercial) daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). Receives: Dietary Supplement: Combination of Lactobacillus probiotics (no comercial) |
| Control group | Placebo comparator | Pregnants will take 1 capsule with maltodextrin daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postpartum Depression
Edinburgh Postnatal Depression Scale (EPDS) (Score min=0; Max=30; The woman will be considered to have PPD if the Edinburgh Survey Scale score is ≥12)
Measured: 12 weeks
Secondary outcomes (9)
Changes in EPDS
Analysis of different scores on the scale EPDS
Measured: 12 weeks
Incidence of anxiety
State-trait Anxiety Inventory (STAI-S) (score ≥40)
Measured: 12 weeks
Changes in STAI-S
Analysis of different scores on the scale STAI-S
Measured: 12 weeks
Assessment of pain during breastfeeding
McGill Pain Questionnaire adapted to breastfeeding
Measured: 12 weeks
Cortisol in breast milk
2 samples (at week 1 postpartum and week 4 postpartum)
Measured: 12 weeks
Cortisol in saliva
3 samples (at the beginning of the study, at week 38 of gestation and at week 4 postpartum)
Measured: 12 weeks
Microbiota in breast milk
2 samples (at week 1 postpartum and week 4 postpartum)
Measured: 12 weeks
Microbiota in mother's feces
2 samples (at the beginning of the study and at week 38 of gestation)
Measured: 12 weeks
Comfort with breastfeeding
Survey on breastfeeding
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: due to its evolution, evaluation, as well as other reasons shared and reviewed between the parties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth Blanco Rojo, PhD, Principal investigator, Biosearch S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651424
- Sponsor's protocol ID
- P060
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Parallel-group Controlled Nutritional Intervention Study to Evaluate the Effect of a Combination of Probiotic Strain on Postpartum Depression
- ClinicalTrials.gov ID
- NCT06651424
- Acronym / sponsor ID
- P060
- Conditions
- Postpartum Depression
- Keywords
- Probiotics, Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to its evolution, evaluation, as well as other reasons shared and reviewed between the parties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Oct 2024 (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.
The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
Detailed description
The mood disorders such as postpartum depression have a very high incidence. There is a relationship between a woman's microbiota and the risk of postpartum depression.
The possibility of influencing the microbiota through probiotic treatments opens a door to the prevention and/or treatment of postpartum depression.
Therefore, the objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Combination of Lactobacillus probiotics (no comercial)Pregnants will take 1 capsule with a combination of probiotics (no comercial) daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). |
| Control group | Placebo comparator | Dietary Supplement: PlaceboPregnants will take 1 capsule with maltodextrin daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant who is between 28-32 weeks of gestation.
- Normal development of pregnancy.
- Singleton pregnancy.
- Score ≥12 scale Postpartum depression questionnaire Edinburgh.
- Pregnant who has the firm intention of breastfeeding her child for at least the first month.
Key exclusion criteria (6 listed)
- Have any breast pathology that makes it difficult or impossible to breastfeed.
- Consume other probiotic supplements during the study.
- History of serious mental disorders other than affective disorders, whether or not currently under pharmacological treatment.
- Low expectation of adherence to the study protocol.
- Pharmacological treatment incompatible with the study.
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 |
|---|---|---|
| Combination of Lactobacillus probiotics (no comercial)Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Experimental group |
| PlaceboEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Control group |
Primary outcome
Incidence of Postpartum Depression
Time frame: 12 weeks
Edinburgh Postnatal Depression Scale (EPDS) (Score min=0; Max=30; The woman will be considered to have PPD if the Edinburgh Survey Scale score is ≥12)
9 secondary outcomes
Changes in EPDS
Time frame: 12 weeks
Incidence of anxiety
Time frame: 12 weeks
Changes in STAI-S
Time frame: 12 weeks
Assessment of pain during breastfeeding
Time frame: 12 weeks
Cortisol in breast milk
Time frame: 12 weeks
Cortisol in saliva
Time frame: 12 weeks
Microbiota in breast milk
Time frame: 12 weeks
Microbiota in mother's feces
Time frame: 12 weeks
Comfort with breastfeeding
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: due to its evolution, evaluation, as well as other reasons shared and reviewed between the parties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Ruth Blanco Rojo, PhD principal investigator
Biosearch S.A.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of Lactobacillus probiotics (no comercial) in people with Postpartum Depression, run by Biosearch S.A. at 3 sites in Spain.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 was stopped early (reason given: due to its evolution, evaluation, as well as other reasons shared and reviewed between the parties). Results are not available in the source record.
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?
Incidence of Postpartum Depression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024.