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This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being.
The study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Fiber Nutritional Supplement with constipation counselling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fiber supplement (PHGG) with counselling for constipation management | Dietary Supplement | fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stool frequency from baseline to 4 weeks of intervention | Change in stool frequency from baseline (V1) to 4 weeks of intervention (V2) assessed using a Gut Health Questionnaire to capture transit time and frequency. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency including presence of diarrhoea | Change in stool consistency from baseline (V1) to 4 weeks of intervention (V2) based on a 7-point Bristol Stool Scale (1=Hard, 7= Watery), including self-reported presence of diarrhoea. | 4 weeks |
| Symptoms of constipation |
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Inclusion Criteria:
Pregnant women aged 21 years-old or above at recruitment
Gestational age of 13-27 weeks at recruitment
Singleton pregnancy at recruitment
Suffering from functional constipation according to the Cullen 2007 criteria which must include ALL the following and the criteria must be fulfilled for at least two weeks with symptom onset during pregnancy:
Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.
Willing and able to comply with the requirements for participation in this study
Willing and able to refrain from consuming other supplements containing fiber, prebiotics, or probiotics other than the Fiber Nutritional Supplement (Materna® Opti-fiber) over the intervention period
Able to respond to questionnaires in English
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Iroz, PhD | Contact | +44763720486 | alison.petit-jean@nestle.com | |
| Irma Silva Zolezzi, PhD | Contact | Irma.SilvaZolezzi@nestle.com |
| Name | Affiliation | Role |
|---|---|---|
| Flávia SantAnna Addor | MEDCIN PESQUISA CLINICA LTDA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Pesquisa Clínica | Osasco | São Paulo | 06023-070 | Brazil |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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open-label, single-arm intervention
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percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week |
| 4 weeks |
| Symptoms of gut discomfort | Frequencey of self-reported presence of abdominal pain, abdominal discomfort abdominal bloating, gassiness / flatulence), and/or pain during defecation (completed at V2 only following 4 weeks of intervention) | 4 weeks |
| Healthcare and pharmacological utilization | Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health | 4 weeks |
| Product acceptance | Self-reported score rom 1 - 5, where 1 = "Very poor", 5 = "Excellent" on product acceptance and ease of use after 4 weeks of intervention (completed at V2 only) using a questionnaire developed for the study. | 4 weeks |