AnxietyPhase 2NCT02711800
The Probiotic Study: Using Bacteria to Calm Your Mind
A Phase 2 study testing Lactobacillus rhamnosus in people with Anxiety and Abdominal Pain, run by Nancy Zucker at 1 site in United States.
Trial summary
The investigators seek to conduct the first open-label trial of probiotics in young children to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the middle-lower GI tract. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Anxiety, Abdominal Pain
- What is being tested?
- Lactobacillus rhamnosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2016to 18 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants need to meet the criteria for functional abdominal pain as specified by the Rome III:
- Scenario #1 Criteria for inclusion
- In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen above the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)
- In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen below the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)
- Scenario #2 Criteria for inclusion 3. In the last 2 months, when the child hurt or felt uncomfortable above (below) the belly button, how often did your child miss school or stop activities? If #1 and #2 is ≥ 2 (or if the combination of #1 and #2 is ≥2) and #3 is ≥ 25% of the time.
- They also have to be at or above cutoff (i.e. TS>= 55) for Beck Youth Inventory (BYI) which can be determined by finding the corresponding raw score, gender, and age on Appendix A in the BYI manual.
Who cannot join
- 1. Participants with immune disorders will be automatically excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Developmental Epedimiology
Durham, North Carolina, 27701
About this study
Official title: Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety
The investigators seek to conduct the first open-label trial of probiotics in young children to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the middle-lower GI tract. Self-report measures and a laboratory task will be collected from children, ages 9-13 years of age, and self-report measures from their primary caregivers prior to and following a 30-day probiotic administration. Children who score above cutoff in anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited sample size and the iterative nature of intervention development, criteria for success at the pilot phase are based primarily on clinical rather than statistical criteria. The study personnel will do their best to keep and ensure the privacy and confidentiality of our participants; however, some of the risks of this study may include psychological discomfort, legal risks, and loss of confidentially.
- Conditions
- Anxiety, Abdominal Pain
- Being tested
- Lactobacillus rhamnosus
- Medical subject headings
- Anxiety Disorders, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosusDrug
Also called Culturelle Kids
The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by the study Co-PI, Dr. Seed. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The treatment duration is 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus rhamnosus | Experimental | The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The intervention duration is 30 days. Receives: Drug: Lactobacillus rhamnosus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Abdominal Pain Rating
Child and parent report is used to obtain ratings of pain intensity on a 0-12 scale. A lower score equates to lower pain intensity. Ratings are obtained for a one-week period pre and post intervention, and measured 3 times daily. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. All time points will be averaged and combined across raters (child and parent) resulting in an average pain severity rating pre and post-treatment. The change in this average rating will be assessed as pain severity outcome. This measure was averaged with the pain frequency average score (see Primary Outcome 2) to result in one primary severity/frequency pain rating pre and post treatment. The change in this combined measure is our primary index of change.
Measured: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Change in Child Abdominal Pain Frequency
Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.
Measured: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Change in Child Anxiety Symptoms
We report the change in magnitude of self-reported state anxiety derived from summed raw scores obtained through the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory at baseline and 30 days from baseline. Scores in the scale range from 6-24, with greater scores indicating worse anxiety. We obtained the summed raw scores after reverse scoring items 1, 4 \& 5.
Measured: Baseline and 30 days
Secondary outcomes (6)
Percentage of Adherence to Treatment
Adherence was calculated as: ("the days probiotic was taken"/"total number of days of treatment") x 100, with results ranging from 0% (no probiotics taken at all) to 100% (probiotics taken 30 days out of the 30 day-treatment period). Researcher will subtract the number of pills/packets taken from the total amount.
Measured: 30 days
Log Fold Change in Relative Quantities of Lactobacillus Among Groups Pre-treatment Relative to Post-probiotic Administration
Examination of the log fold change in relative quantities of Lactobacillus calculated from fecal samples gathered pre-probiotic administration and post-probiotic administration. Analyses represent the log-fold change from post-treatment - pre-treatment quantities.
Measured: Baseline and 30 days
Log Fold Change in Alpha Diversity
Log Fold Change in the alpha species diversity from pre-treatment (prior to probiotic administration) to post probiotic administration.
Measured: Baseline and 30 days
Log Fold Change in Beta Diversity
An examination of the pre-treatment to post-treatment log fold change in the regional and local changes in species characterized in the microbiome.
Measured: Baseline and 30 days
Change in Salivary Cortisol (ug/dL)
A measure of cortisol based on the analysis of saliva samples collected throughout a Trier Social Stress Test.
Measured: Baseline and 30 days
Change in Heart Rate
Beats per minute (Bpm)
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start8 Nov 2016
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Zucker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nancy Zucker, Duke University
- Investigators
- Nancy Zucker, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711800
- Sponsor's protocol ID
- Pro00063870
- Status last verified
- May 2026
- First submitted
- 22 Jan 2016
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Given the pilot nature of the study, resulting data may not be appropriate for sharing within a larger data repository. We will change this policy if we learn otherwise.
Publications
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety
- ClinicalTrials.gov ID
- NCT02711800
- Acronym / sponsor ID
- Pro00063870
- Conditions
- Anxiety, Abdominal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nancy ZuckerUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators seek to conduct the first open-label trial of probiotics in young children to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the middle-lower GI tract. Self-report measures and a laboratory task will be collected from children, ages 9-13 years of age, and self-report measures from their primary caregivers prior to and following a 30-day probiotic administration. Children who score above cutoff in anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited sample size and the iterative nature of intervention development, criteria for success at the pilot phase are based primarily on clinical rather than statistical criteria. The study personnel will do their best to keep and ensure the privacy and confidentiality of our participants; however, some of the risks of this study may include psychological discomfort, legal risks, and loss of confidentially.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhamnosus | Experimental | Drug: Lactobacillus rhamnosusThe investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The intervention duration is 30 days. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants need to meet the criteria for functional abdominal pain as specified by the Rome III:
- Scenario #1 Criteria for inclusion
- In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen above the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)
- In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen below the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)
- Scenario #2 Criteria for inclusion 3. In the last 2 months, when the child hurt or felt uncomfortable above (below) the belly button, how often did your child miss school or stop activities? If #1 and #2 is ≥ 2 (or if the combination of #1 and #2 is ≥2) and #3 is ≥ 25% of the time.
Key exclusion criteria (1 listed)
- 1. Participants with immune disorders will be automatically excluded from this study.
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 |
|---|---|---|
| Lactobacillus rhamnosusAlso: Culturelle KidsThe investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by the study Co-PI, Dr. Seed. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The treatment duration is 30 days. | Drug | Lactobacillus rhamnosus |
Primary outcome
Change in Child Abdominal Pain Rating
Time frame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Child and parent report is used to obtain ratings of pain intensity on a 0-12 scale. A lower score equates to lower pain intensity. Ratings are obtained for a one-week period pre and post intervention, and measured 3 times daily. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. All time points will be averaged and combined across raters (child and parent) resulting in an average pain severity rating pre and post-treatment. The change in this average rating will be assessed as pain severity outcome. This measure was averaged with the pain frequency average score (see Primary Outcome 2) to result in one primary severity/frequency pain rating pre and post treatment. The change in this combined measure is our primary index of change.
Change in Child Abdominal Pain Frequency
Time frame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.
Change in Child Anxiety Symptoms
Time frame: Baseline and 30 days
We report the change in magnitude of self-reported state anxiety derived from summed raw scores obtained through the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory at baseline and 30 days from baseline. Scores in the scale range from 6-24, with greater scores indicating worse anxiety. We obtained the summed raw scores after reverse scoring items 1, 4 \& 5.
6 secondary outcomes
Percentage of Adherence to Treatment
Time frame: 30 days
Log Fold Change in Relative Quantities of Lactobacillus Among Groups Pre-treatment Relative to Post-probiotic Administration
Time frame: Baseline and 30 days
Log Fold Change in Alpha Diversity
Time frame: Baseline and 30 days
Log Fold Change in Beta Diversity
Time frame: Baseline and 30 days
Change in Salivary Cortisol (ug/dL)
Time frame: Baseline and 30 days
Change in Heart Rate
Time frame: Baseline and 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1393159Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Individual participant dataSharing planned: No. Given the pilot nature of the study, resulting data may not be appropriate for sharing within a larger data repository. We will change this policy if we learn otherwise.
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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.
Nancy Zucker, Ph.D. principal investigator
Duke University
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 Lactobacillus rhamnosus in people with Anxiety and Abdominal Pain, run by Nancy Zucker at 1 site in United States.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Child Abdominal Pain Rating (time frame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711800, which also lists 1 linked publication.
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 10 Jun 2026.