Abdominal DiscomfortPhase 2NCT01893814
Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort
A Phase 2 study testing Probiotics in people with Abdominal Discomfort, run by Probi AB at 1 site in Germany.
Trial summary
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort. Read more about this study
- Who is it for?
- Ages 2 to 12 weeks
- Conditions the study is for
- Abdominal Discomfort
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Jan 2014
- Phase
- Phase 2
- 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 2 to 12 weeks
- All sexes
- Child
Who may be able to join
- Male or female singleton
- ≥ 2 weeks and ≤ 12 weeks of age
- Exclusively breastfed at screening
- Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
- Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
- Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study
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- Born at full term (37-42 after last menstruation period)
- Birth weight: 2500 - 4500 g
- Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts
- Apparently healthy at birth (Apgar ≥ 8) and at screening visit
- No major complications during pregnancy or at birth
- Mother 19-45 years of age at childbirth
- Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires
Who cannot join
- Intolerance to investigational product/its ingredients
- Severe medical condition or illness, congenital abnormality
- Gastrointestinal disorders (e.g. reflux esophagitis)
- Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
- Formula feeding at screening/randomisation
- Allergy or atopic disease (family history)
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- Participation in another study
- Mother's health condition that may interfere with her ability to take care of her infant
- Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome
- Use of antibiotics by the mother in the week
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.
- Conditions
- Abdominal Discomfort
- Being tested
- Probiotics, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
ControlDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Not described Receives: Dietary Supplement: Probiotics |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of abdominal discomfort as assessed by comparison of crying time
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal DiscomfortStudies 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 2
- Primary purpose
- Treatment
- 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
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893814
- Sponsor's protocol ID
- PAB/029911
- Status last verified
- Sep 2016
- First submitted
- 2 Jul 2013
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort
- ClinicalTrials.gov ID
- NCT01893814
- Acronym / sponsor ID
- PAB/029911
- Conditions
- Abdominal Discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- First posted
- 9 Jul 2013 (estimated)
- 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.
To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotics |
| Control | Placebo comparator | Dietary Supplement: Control |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male or female singleton
- ≥ 2 weeks and ≤ 12 weeks of age
- Exclusively breastfed at screening
- Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
- Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
Key exclusion criteria (10 listed)
- Intolerance to investigational product/its ingredients
- Severe medical condition or illness, congenital abnormality
- Gastrointestinal disorders (e.g. reflux esophagitis)
- Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
- Formula feeding at screening/randomisation
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 |
|---|---|---|
| Probiotics | Dietary supplement | Probiotics |
| Control | Dietary supplement | Control |
Primary outcome
Reduction of abdominal discomfort as assessed by comparison of crying time
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics in people with Abdominal Discomfort, run by Probi AB at 1 site in Germany.
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 13 inclusion and 10 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). 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?
Reduction of abdominal discomfort as assessed by comparison of crying time (time frame: 28 days). 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 22 Sep 2016.