Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000239561
Ethics application status
Approved
Date submitted
18/02/2015
Date registered
17/03/2015
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics in Pregnancy and Group B Streptococcal Colonization
Scientific title
Randomized Double-blind Placebo-controlled Trial of Probiotics in Pregnancy and its effect on Group-B Streptococcal Colonization
Secondary ID [1] 286209 0
Nil Known
Universal Trial Number (UTN)
U1111-1166-6005
Trial acronym
PIP - Probiotics in pregnancy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Group B Streptoccal Colonization in Pregnancy 294252 0
Condition category
Condition code
Reproductive Health and Childbirth 294568 294568 0 0
Antenatal care
Infection 294754 294754 0 0
Other infectious diseases
Reproductive Health and Childbirth 294755 294755 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Dietary Supplement: Probiotic dietary supplement or Placebo
Dietary Supplement: Probiotic genus & species Strain Active count. Lactobacillus acidophilus (helveticus) 4.35 Billion cfu, Lactobacillus rhamnosus 4.35 Billon cfu, Bifidobacterium longum 4.35 Billion cfu, Saccharomyces boulardii 1.95 Billon cfu, Other Names: -Gastrohealth 4 (Pharmacare Pty Ltd)


Other Names:
-Gastrohealth 4 (Pharmacare Pty Ltd)
Study Arm (s)
- Active Comparator: Probiotic dietary supplement, one capsule once daily until delivery.

The investigators will schedule the women for routine monthly obstetric visits (more often if clinically required) during which time they will also meet with one of the investigators. The investigator at each monthly visit will provide an additional monthly allotment of 30 capsules. The capsule bottle from the previous cycle will be collected and dated if there are capsules remaining in the bottle. Remaining capsules will be counted and refrigerated for future use.
Intervention code [1] 291223 0
Treatment: Drugs
Intervention code [2] 291346 0
Prevention
Comparator / control treatment
-Placebo Comparator: Placebo capsule (sugar pill), one daily until delivery.
Control group
Placebo

Outcomes
Primary outcome [1] 294341 0
Group B Streptococcus (GBS) maternal rectovaginal colonization indicated by positive culture of rectovaginal swab
Timepoint [1] 294341 0
at 35-37 weeks of pregnancy
Secondary outcome [1] 313072 0
Neonatal GBS infection/meningitis - blood and or CSF culture (as needed clinically)
Timepoint [1] 313072 0
Birth to 28 days
Secondary outcome [2] 313395 0
Suspected or proven Neonatal non-GBS Sepsis - blood culture/CSF culture (as needed clinically)
Timepoint [2] 313395 0
Birth-28 days
Secondary outcome [3] 313396 0
Gestational Diabetes - Routine Maternal Blood sugar Screen (as normally indicated in pregancy)
Timepoint [3] 313396 0
26-28 weeks's gestation
Secondary outcome [4] 313397 0
Preeclampsia/Pregnancy Induced Hypertension - Clinical notes review for maternal BP
Timepoint [4] 313397 0
Recruitment to Delivery
Secondary outcome [5] 313398 0
Chorioamnionitis- Placental Culture
Timepoint [5] 313398 0
Delivery/Birth
Secondary outcome [6] 313399 0
Bacterial Vaginosis - vaginal swabs culture
Timepoint [6] 313399 0
Monthly from recuitment to delivery
Secondary outcome [7] 313400 0
Atopic Dermatitis/Eczema - Clinical diagnosis by Paediatrician/Neonatologist/Dermatologist and/or Blood test for IgE and/or skin prick testing (as needed clinically). This outcome applies to infants only.
Timepoint [7] 313400 0
8 weeks to one year of age
Secondary outcome [8] 313533 0
Preterm Birth : gestation less than 37 weeks based on Expected date of delivery
Timepoint [8] 313533 0
at Birth

Eligibility
Key inclusion criteria
1. Pregnant women between 23-28 weeks gestation.
2. 18-55 years of age
3. Singleton gestation
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pre-existing morbidity:
* inflammatory bowel disease (Crohn's disease or ulcerative colitis);
* stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter,
* Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states);
*Type 1 diabetes and type 2 diabetes;
*congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labour; pulmonary disease (except mild asthma);
*renal disease;
* chronic hepatic disease (Hepatitis B, C);
2. Multi-foetal gestation.
3.Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
4. Chronic (daily) use of broad spectrum antibiotics.
5. History of infant with GBS sepsis.
6. Foetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
7. Anticipated delivery <35 weeks for maternal/foetal indication
8. Placenta Previa or accreta (with anticipated delivery prior to 35 weeks)
9. Women with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
430
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3473 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 290870 0
Charities/Societies/Foundations
Name [1] 290870 0
WA Department of Health and Telethon
Country [1] 290870 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Department of Neonatology, Fiona Stanley Hospital, 102-118 Murdoch Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 289560 0
None
Name [1] 289560 0
Address [1] 289560 0
Country [1] 289560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292408 0
Women's and Newborn Health Service Human Research Ethics Committee
Ethics committee address [1] 292408 0
Ethics committee country [1] 292408 0
Australia
Date submitted for ethics approval [1] 292408 0
27/11/2015
Approval date [1] 292408 0
15/03/2016
Ethics approval number [1] 292408 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55082 0
Dr Shailender Mehta
Address 55082 0
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
Country 55082 0
Australia
Phone 55082 0
+61861522222
Fax 55082 0
Email 55082 0
[email protected]
Contact person for public queries
Name 55083 0
Shailender Mehta
Address 55083 0
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
Country 55083 0
Australia
Phone 55083 0
+61861522222
Fax 55083 0
Email 55083 0
[email protected]
Contact person for scientific queries
Name 55084 0
Shailender Mehta
Address 55084 0
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
Country 55084 0
Australia
Phone 55084 0
+61861522222
Fax 55084 0
Email 55084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.