A clinical study to assess the efficacy of a probiotic supplement for women to reduce depression and anxiety symptoms after giving birth
| ISRCTN | ISRCTN99047904 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99047904 |
| Secondary identifying numbers | K.E.HU.NN.NGN00.000.00.00_2019/FV |
- Submission date
- 22/11/2021
- Registration date
- 24/11/2021
- Last edited
- 17/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The existence of communication between the brain and the gut, known as the Gut-Brain axis, has for long been recognized. Consequently, the importance of maintaining a healthy microbiota (microorganisms including bacteria that live in the digestive tract) community in the regulation of the gut-brain axis is of paramount importance. Probiotic supplementation has been suggested to maintain, through gut microbiota modulation, the physiological state of the mental and physical well-being. In this context the use of probiotics could be of support to new-mothers to reduce the possibility of the onset of anxiety or stress after childbirth.
Who can participate?
Pregnant healthy women with no clinical history of depression.
What does the study involve?
The study involves the administration of two different food supplements for 90 days after giving birth: one with probiotics + vitamins and the other with vitamins only.
What are the possible benefits and risks of participating?
Risks associated with the intake of the product are considered from low to very low. Benefits associated with product use are amelioration of symptoms of depression and anxiety, of incidence of mastitis episodes, and of crying episodes of the child.
Where is the study run from?
Humanitas San Pio X Hospital (Italy)
When is the study starting and how long is it expected to run for?
September 2020 to July 2021
Who is funding the study?
Roelmi HPC (Italy)
Who is the main contact?
Dr Franco Vicariotto, ginecologia@vicariotto.com
Contact information
Scientific
Humanitas San Pio X Hospital
Via Francesco Nava, 31
Milan
20159
Italy
| Phone | +39 3356698020 |
|---|---|
| ginecologia@vicariotto.com |
Study information
| Study design | Multicenter randomized double-blind controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized double blind controlled clinical study to assess the effect of treatment with a probiotic supplement targeted to women after pregnancy, to reduce postpartum symptoms of depression and anxiety |
| Study objectives | The probiotic supplement is able to re-establish the microbial homeostasis in the gut and might positively influence the neural activity, resulting in the incidence reduction of depression or anxiety symptoms and post-natal stress. |
| Ethics approval(s) | Approved 13/11/2019, Independent Ethics Committee for Non-Pharmacological Clinical Investigations (Via XX Settembre 30/4, 16121 Genova - Italy; +39 105454842; ssinf@messaggipec.it), ref: 2019/12 |
| Health condition(s) or problem(s) studied | Improvement of post-partum depression and mastitis in healthy new mothers and reduction of excessive crying in the newborns. |
| Intervention | 2 groups of 100 subjects were invited to orally take one capsule/day for 90 days, starting from delivery, as follows: one group (A) used the complete active treatment (Probiotics mix + multivitamin food supplement), one group (B) used the reference treatment (multivitamin food supplement). A restricted randomization list is generated by the site Study Coordinator using an appropriate statistic algorithm (“Wey’s urn”). |
| Intervention type | Supplement |
| Primary outcome measure | Depression and anxiety symptoms and post-natal stress measured using the Edinburgh Postnatal Depression Scale (EPDS) after 45 and 90 days |
| Secondary outcome measures | 1. Baby's crying, measured using Breastfeeding Self Efficacy Scale Short Form and Children Cry Questionnaires after 45 and 90 days. 2. Mastitis measured using Breastfeeding Quality Questionnaire after 45 and 90 days |
| Overall study start date | 07/09/2019 |
| Completion date | 26/07/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 200 |
| Key inclusion criteria | Healthy pregnant female subjects after their delivery |
| Key exclusion criteria | 1. Subjects who do not meet the inclusion criteria 2. Subjects considered as not adequate to participate to the study by the investigator 3. Subjects with known or suspected sensitization to one or more test formulation ingredients 4. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 5. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function 6. Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder 7. Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe 8. A significant risk of infanticide according to the investigator assessment 9. Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study 10. Receiving counseling or psychological therapies at baseline or during the study 11. Participation in any clinical trial within the previous 3 months prior to baseline |
| Date of first enrolment | 21/07/2020 |
| Date of final enrolment | 15/05/2021 |
Locations
Countries of recruitment
- Italy
Study participating centres
Milan
20159
Italy
Rome
00184
Italy
Flornce
50134
Italy
Caserta
81100
Italy
Siena
53100
Italy
Udine
33100
Italy
Naples
80138
Italy
Rome
00168
Italy
Rome
00189
Italy
Rome
00189
Italy
Sponsor information
Industry
Via Celeste Milani 24
Origgio (VA)
21040
Italy
| Phone | +39 0233510150 |
|---|---|
| federica.carlomagno@roelmihpc.com | |
| Website | http://www.roelmihpc.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 09/08/2023 | 17/01/2024 | Yes | No |
Editorial Notes
17/01/2024: Publication reference added.
23/11/2021: Trial's existence confirmed by Independent Ethics Committee for Non-Pharmacological Clinical Investigations.
