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A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.

ConditionHealthy Adults Reporting Recurrent Gastrointestinal Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovonesis

About this trial

This real-world study conducted in the U.S.A aims to understand how gastrointestinal (GI) symptoms and wellbeing, including mood, sleep, and eating behaviours, change over time in 300 adults who choose to take a probiotic dietary supplement (often called "good bacteria", like the kind found in yogurt). This study looks at how a probiotic supplement may affect digestive symptoms and wellbeing.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Females or males at least 18 years of age at the planned start date.

Reporting mild-to-moderate GI symptoms at screening, defined as recurrent abdominal pain or discomfort at least 3 days per month on average in the last 3 months, associated with bowel movement (either improvement or exacerbation), and a change in the form and/or frequency of bowel movements, with initial onset of symptoms at least 6 months ago. An adaptive design will allow recruitment of participants with initial onset of at least 3 months ago, in case of recruitment delays.

Owner of a personal smartphone which: (i) only they have access to, and (ii) has Apple AppStore or Android store access to the free-to-use Trialflare app.

Consume the dietary supplement daily for the duration of the study

Disqualifiers

Pregnant, breastfeeding, or planning pregnancy during the study period

Known allergy or intolerance to any component of the study product

Coeliac disease

Inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis

Trial design

Design model

Single group

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    Two capsules to be self-administered orally once daily, each containing 5 x 10\^9 colony-forming units (CFU) of Bifidobacterium longum (1714™) and Bifidobacterium longum (35624™) combined, equating to a total daily probiotic dose of 1 x 10\^10 CFU, for 12 weeks.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: ProbioticExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in PROMIS Belly Pain 5a T-score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From baseline to end of week 12

Secondary outcomes

1

Mean change in PROMIS Diarrhea 6a T-score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From baseline to end of week 12
2

Mean change in PROMIS Constipation 9a T-score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From baseline to end of week 12
3

Mean change in PROMIS Gas and Bloating 13a (v1.1) T-score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From baseline to end of week 12
4

Mean change in PROMIS Emotional Distress - Anxiety 6a T-score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From baseline to end of week 12

Other outcomes

1

Mean changes during probiotic wash-out in PROMIS T-scores (all GI and psychosocial domains respectively)

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From end of week 12 to end of week 16
2

Mean changes during probiotic wash-out in Visual Analogue Mood Scale (VAMS) score

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From end of week 12 to end of week 16
3

Mean changes during probiotic wash-out in self-reported dietary behaviours

Data collection time-points: Weeks 0 (Baseline), 4, 8, 12, 16

Time frame
From end of week 12 to end of week 16
4

Mean change in cortisol awakening response, as measured using salivary cortisol samples

Time frame
From baseline to end of week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novonesis

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: