Typhoid CarrierPhase 2NCT07908030
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
A Phase 2 study testing Curcumin extract and Ciprofloxacin in people with Typhoid Carrier and Typhoid Fever, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
Some people keep carrying Salmonella Typhi after they recover from typhoid fever. These carriers have no symptoms. They can still pass the bacteria into food. Food handlers in the Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) cook for many school children every day. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Carrier, Typhoid Fever, Salmonella Typhi Infection
- What is being tested?
- Curcumin extract and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Nov 2026to 22 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60 years.
- Works as a food handler in a kitchen of the Free Nutritious Meal Program (MBG) in Surakarta.
- Willing to give a blood sample and a rectal swab.
- Gives written informed consent.
- Additional Inclusion Criteria (stage 2, randomized trial):
- Widal test with a Vi or O/H titer above 1/160.
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- Rectal swab culture positive for Salmonella Typhi, confirmed by IMViC biochemical tests.
- No fever or other signs of acute typhoid fever at randomization.
- Willing to take the study drugs for 28 days and to return for a repeat rectal swab.
Who cannot join
- Known allergy to ciprofloxacin, other fluoroquinolones, curcumin, or turmeric.
- Pregnant or breastfeeding.
- Acute typhoid fever or another acute febrile illness that needs treatment.
- Antibiotic use within 2 weeks before randomization.
- Regular use of turmeric or curcumin supplements within 4 weeks before randomization.
- Known severe liver disease or chronic kidney disease.
- Current use of anticoagulant or antiplatelet drugs.
- History of tendon disorder or myasthenia gravis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
About this study
Official title: The Potential of Curcumin Extract as an Adjuvant Therapy in the Eradication of Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program (Program Makan Bergizi Gratis): Carrier Screening Followed by a Randomized, Double-Blind, Placebo-Controlled Trial
Some people keep carrying Salmonella Typhi after they recover from typhoid fever. These carriers have no symptoms. They can still pass the bacteria into food. Food handlers in the Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) cook for many school children every day. One carrier in an MBG kitchen can cause an outbreak.
Standard antibiotics often fail to clear the carrier state. The bacteria form a biofilm on gallstones. This biofilm protects them from antibiotics. Curcumin is the main active compound of turmeric. In laboratory studies, curcumin weakens the biofilm. It may also help ciprofloxacin stay longer inside the bacteria.
Read more
This study has two stages. In stage 1, the study team screens 100 MBG food handlers in Surakarta, Indonesia. Each person gives a blood sample for the Widal test. People with a high Widal titer give a rectal swab for culture. In stage 2, people with a positive Salmonella Typhi culture are randomly assigned to one of two groups. One group takes ciprofloxacin plus curcumin extract. The other group takes ciprofloxacin plus placebo. Treatment lasts 28 days.
The main question is whether curcumin added to ciprofloxacin clears Salmonella Typhi better than ciprofloxacin alone. The main outcome is a negative rectal swab culture 30 days after treatment ends.
Read the detailed description
Background
Indonesia has a high burden of typhoid fever. A chronic carrier is a healthy person who keeps shedding Salmonella Typhi in the stool after the illness. The gallbladder is the main site of carriage. Gallstones raise the risk of long-term carriage. Carriers do not feel sick. Because of this, they are rarely found and rarely treated.
The Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) is a national program. Each MBG kitchen serves meals to many schools. A food handler who is a carrier can spread the bacteria to many children at once. Finding and treating carriers among food handlers can protect food safety at the source.
Fluoroquinolones such as ciprofloxacin are used to treat carriers. Treatment often fails. Salmonella Typhi forms a biofilm on gallstones. The biofilm is made of sugars, proteins, and DNA. It blocks the entry of antibiotics. Curcumin from Curcuma longa has shown anti-biofilm effects in laboratory studies. It lowers the genes that control biofilm matrix production. It may also block bacterial efflux pumps. This may keep more ciprofloxacin inside the bacteria. Most of this evidence comes from in vitro and animal studies. This study tests the idea in people.
Objectives
- To measure the prevalence of typhoid carriage among MBG food handlers in Surakarta.
- To compare the eradication rate of Salmonella Typhi between ciprofloxacin plus curcumin extract and ciprofloxacin plus placebo in confirmed carriers.
Study design
This is a two-stage study done in Surakarta, Central Java, Indonesia. The study runs for about 24 months. Recruitment is done with the Surakarta City Health Office.
Stage 1. Carrier screening
The study team invites food handlers working in MBG kitchens in Surakarta. About 100 food handlers will join after written informed consent. The team collects basic data with a questionnaire. Each participant gives a venous blood sample for the Widal test. A Vi or O/H titer above 1/160 is counted as a suspected carrier. Suspected carriers give a rectal swab. The swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. A participant with a positive culture is a confirmed carrier. Participants with a negative Widal test or a negative culture end their study participation after stage 1. All confirmed carriers are referred for care and are offered entry into stage 2.
Stage 2. Randomized controlled trial
Confirmed carriers who meet the eligibility criteria are randomly assigned in a 1:1 ratio to one of two arms. The trial is double-blind. Participants and investigators do not know the group assignment. Curcumin capsules and placebo capsules look the same.
Arm 1 receives ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days.
Arm 2 receives ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days.
The team checks adherence during treatment with pill counts and a daily log. Adherence above 90% is the target. The team also records adverse events. A repeat rectal swab culture is done 30 days after the last dose.
Outcomes
The primary outcome is eradication. Eradication means no growth of Salmonella Typhi in the rectal swab culture 30 days after treatment ends. Secondary outcomes are adherence, adverse events, and the prevalence of carriage among screened food handlers.
Statistical analysis
The proportion of participants with eradication is compared between the two arms. The chi-square test or Fisher's exact test is used. A p value below 0.05 is considered significant.
Ethics
The protocol (version 2) was approved by the Research Ethics Committee of Universitas Sebelas Maret Hospital (No. 196.1/UN27.46/TA.04.19/KEP/EC/2026). The approval follows the 7 WHO 2011 standards and the 2016 CIOMS guidelines. All participants give written informed consent.
Funding
This study is funded by Universitas Sebelas Maret through the Penelitian Fundamental B (PFB-UNS) research grant, 2026 (registration number 00070574055812026).
- Conditions
- Typhoid Carrier, Typhoid Fever, Salmonella Typhi Infection
- Being tested
- Curcumin extract, Ciprofloxacin, Placebo
- Keywords
- Curcumin, Ciprofloxacin, Chronic carrier, Food handlers, Biofilm, Food safety, Free Nutritious Meal Program, Indonesia
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin extractDietary supplement
Also called Curcuma longa extract, Turmeric extract
Curcumin extract capsules, 1,000 mg per day by mouth for 28 days. Given together with ciprofloxacin.
CiprofloxacinDrug
Ciprofloxacin 500 mg tablet by mouth twice daily for 28 days. Both arms receive ciprofloxacin.
PlaceboOther
Capsules filled with amylum (starch). They look the same as the curcumin capsules. Taken on the same schedule for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin + Curcumin Extract | Experimental | Culture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days. Receives: Dietary Supplement: Curcumin extract; Drug: Ciprofloxacin |
| Ciprofloxacin + Placebo | Placebo comparator | Culture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days. The placebo capsules look the same as the curcumin capsules. Receives: Drug: Ciprofloxacin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with negative Salmonella Typhi culture (eradication)
A rectal swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. Eradication means no growth of Salmonella Typhi. The proportion is compared between the two arms.
Measured: 30 days after the end of the 28-day treatment
Secondary outcomes (3)
Treatment adherence
Percentage of prescribed capsules taken. Measured by pill count and a daily intake log. Adherence above 90% is counted as good adherence.
Measured: Day 1 to day 28 of treatment
Number of participants with adverse events
Adverse events are recorded at each monitoring visit. They include gastrointestinal complaints, skin reactions, and any other event reported by the participant or found by the investigator.
Measured: From the first dose to 30 days after the end of the 28-day treatment
Prevalence of typhoid carriage among screened food handlers
Number of food handlers with culture-confirmed Salmonella Typhi carriage divided by the number of food handlers screened, expressed as a percentage.
Measured: At screening (stage 1, before randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid CarrierStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
- Investigators
- Nurhasan Agung Prabowo, dr., Sp.PD., M.Kes., Principal investigator, Universitas Sebelas MaretTonang Dwi Ardyanto, Prof., dr., Sp.PK(K), Ph.D., Study chair, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908030
- Sponsor's protocol ID
- PFB-UNS-00070574055812026
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Curcumin Extract as an Adjuvant Therapy in the Eradication of Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program (Program Makan Bergizi Gratis): Carrier Screening Followed by a Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07908030
- Acronym / sponsor ID
- PFB-UNS-00070574055812026
- Conditions
- Typhoid Carrier, Typhoid Fever, Salmonella Typhi Infection
- Keywords
- Curcumin, Ciprofloxacin, Chronic carrier, Food handlers, Biofilm, Food safety, Free Nutritious Meal Program, Indonesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- 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.
Some people keep carrying Salmonella Typhi after they recover from typhoid fever. These carriers have no symptoms. They can still pass the bacteria into food. Food handlers in the Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) cook for many school children every day. One carrier in an MBG kitchen can cause an outbreak.
Standard antibiotics often fail to clear the carrier state. The bacteria form a biofilm on gallstones. This biofilm protects them from antibiotics. Curcumin is the main active compound of turmeric. In laboratory studies, curcumin weakens the biofilm. It may also help ciprofloxacin stay longer inside the bacteria.
This study has two stages. In stage 1, the study team screens 100 MBG food handlers in Surakarta, Indonesia. Each person gives a blood sample for the Widal test. People with a high Widal titer give a rectal swab for culture. In stage 2, people with a positive Salmonella Typhi culture are randomly assigned to one of two groups. One group takes ciprofloxacin plus curcumin extract. The other group takes ciprofloxacin plus placebo. Treatment lasts 28 days.
The main question is whether curcumin added to ciprofloxacin clears Salmonella Typhi better than ciprofloxacin alone. The main outcome is a negative rectal swab culture 30 days after treatment ends.
Detailed description
Background
Indonesia has a high burden of typhoid fever. A chronic carrier is a healthy person who keeps shedding Salmonella Typhi in the stool after the illness. The gallbladder is the main site of carriage. Gallstones raise the risk of long-term carriage. Carriers do not feel sick. Because of this, they are rarely found and rarely treated.
The Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) is a national program. Each MBG kitchen serves meals to many schools. A food handler who is a carrier can spread the bacteria to many children at once. Finding and treating carriers among food handlers can protect food safety at the source.
Fluoroquinolones such as ciprofloxacin are used to treat carriers. Treatment often fails. Salmonella Typhi forms a biofilm on gallstones. The biofilm is made of sugars, proteins, and DNA. It blocks the entry of antibiotics. Curcumin from Curcuma longa has shown anti-biofilm effects in laboratory studies. It lowers the genes that control biofilm matrix production. It may also block bacterial efflux pumps. This may keep more ciprofloxacin inside the bacteria. Most of this evidence comes from in vitro and animal studies. This study tests the idea in people.
Objectives
- To measure the prevalence of typhoid carriage among MBG food handlers in Surakarta.
- To compare the eradication rate of Salmonella Typhi between ciprofloxacin plus curcumin extract and ciprofloxacin plus placebo in confirmed carriers.
Study design
This is a two-stage study done in Surakarta, Central Java, Indonesia. The study runs for about 24 months. Recruitment is done with the Surakarta City Health Office.
Stage 1. Carrier screening
The study team invites food handlers working in MBG kitchens in Surakarta. About 100 food handlers will join after written informed consent. The team collects basic data with a questionnaire. Each participant gives a venous blood sample for the Widal test. A Vi or O/H titer above 1/160 is counted as a suspected carrier. Suspected carriers give a rectal swab. The swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. A participant with a positive culture is a confirmed carrier. Participants with a negative Widal test or a negative culture end their study participation after stage 1. All confirmed carriers are referred for care and are offered entry into stage 2.
Stage 2. Randomized controlled trial
Confirmed carriers who meet the eligibility criteria are randomly assigned in a 1:1 ratio to one of two arms. The trial is double-blind. Participants and investigators do not know the group assignment. Curcumin capsules and placebo capsules look the same.
Arm 1 receives ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days.
Arm 2 receives ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days.
The team checks adherence during treatment with pill counts and a daily log. Adherence above 90% is the target. The team also records adverse events. A repeat rectal swab culture is done 30 days after the last dose.
Outcomes
The primary outcome is eradication. Eradication means no growth of Salmonella Typhi in the rectal swab culture 30 days after treatment ends. Secondary outcomes are adherence, adverse events, and the prevalence of carriage among screened food handlers.
Statistical analysis
The proportion of participants with eradication is compared between the two arms. The chi-square test or Fisher's exact test is used. A p value below 0.05 is considered significant.
Ethics
The protocol (version 2) was approved by the Research Ethics Committee of Universitas Sebelas Maret Hospital (No. 196.1/UN27.46/TA.04.19/KEP/EC/2026). The approval follows the 7 WHO 2011 standards and the 2016 CIOMS guidelines. All participants give written informed consent.
Funding
This study is funded by Universitas Sebelas Maret through the Penelitian Fundamental B (PFB-UNS) research grant, 2026 (registration number 00070574055812026).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin + Curcumin Extract | Experimental | Dietary Supplement: Curcumin extract, Drug: CiprofloxacinCulture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days. |
| Ciprofloxacin + Placebo | Placebo comparator | Drug: Ciprofloxacin, Other: PlaceboCulture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days. The placebo capsules look the same as the curcumin capsules. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 60 years.
- Works as a food handler in a kitchen of the Free Nutritious Meal Program (MBG) in Surakarta.
- Willing to give a blood sample and a rectal swab.
- Gives written informed consent.
- Widal test with a Vi or O/H titer above 1/160.
Key exclusion criteria (8 listed)
- Known allergy to ciprofloxacin, other fluoroquinolones, curcumin, or turmeric.
- Pregnant or breastfeeding.
- Acute typhoid fever or another acute febrile illness that needs treatment.
- Antibiotic use within 2 weeks before randomization.
- Regular use of turmeric or curcumin supplements within 4 weeks before randomization.
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 |
|---|---|---|
| Curcumin extractAlso: Curcuma longa extract, Turmeric extractCurcumin extract capsules, 1,000 mg per day by mouth for 28 days. Given together with ciprofloxacin. | Dietary supplement | Ciprofloxacin + Curcumin Extract |
| CiprofloxacinCiprofloxacin 500 mg tablet by mouth twice daily for 28 days. Both arms receive ciprofloxacin. | Drug | Ciprofloxacin + Curcumin Extract, Ciprofloxacin + Placebo |
| PlaceboCapsules filled with amylum (starch). They look the same as the curcumin capsules. Taken on the same schedule for 28 days. | Other | Ciprofloxacin + Placebo |
Primary outcome
Proportion of participants with negative Salmonella Typhi culture (eradication)
Time frame: 30 days after the end of the 28-day treatment
A rectal swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. Eradication means no growth of Salmonella Typhi. The proportion is compared between the two arms.
3 secondary outcomes
Treatment adherence
Time frame: Day 1 to day 28 of treatment
Number of participants with adverse events
Time frame: From the first dose to 30 days after the end of the 28-day treatment
Prevalence of typhoid carriage among screened food handlers
Time frame: At screening (stage 1, before randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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.
Nurhasan Agung Prabowo, dr., Sp.PD., M.Kes. principal investigator
Universitas Sebelas Maret
Tonang Dwi Ardyanto, Prof., dr., Sp.PK(K), Ph.D. study chair
Universitas Sebelas Maret
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 Curcumin extract and Ciprofloxacin in people with Typhoid Carrier and Typhoid Fever, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Oct 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurhasan Agung Prabowo, dr., Sp.PD., M.Kes. (+62 823 2801 0430, dr.nurhasan21@staff.uns.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with negative Salmonella Typhi culture (eradication) (time frame: 30 days after the end of the 28-day treatment). 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 30 Oct 2026.