In this group, the patients received 100mg ferrous succinate and 200mg vitamin C three times per day for 3-4 months

In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months

In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months

Anemia, Iron-Deficiency

As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time

ferrous succinate and vitamin C

As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

ferrous succinate

As another active comparator, patients take the tablets of ferrous succinate with double dosage

Hushan Hospital

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week

The increased levels of reticulocyte after receiving three different treatment regimens are evaluated in the second week

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the fourth week

The increased levels of ferritin after receiving three different treatment regimens are evaluated in the eighth week

The incidence of adverse events every two weeks are assessed, the adverse events include bellyache, diarrhea, constipation, vomiting, nausea.

xiao-qin wang

professor

Huashan Hospital

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

CJCV1 2 μg / Alum 0 μg (1A)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)

CJCV1 2 μg / Alum 125 μg (1B)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

CJCV1 5 μg / Alum 0 μg (2A)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)

CJCV1 5 μg / Alum 125 μg (2B)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

CJCV1 10 μg / Alum 0 μg (3A)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
Capsule-Conjugate Campylobacter Vaccine (CJCV1): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)

CJCV1 10 μg / Alum 125 μg (1A)

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.

Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)

Primary immunologic parameters, serum samples were assessed for the antibody titers against Campylobacter jejuni conjugate vaccine1 (CJCV1) using ELISA (enzyme-linked immunosorbent assay) based methods.
Antibody-secreting cell(s) (ASCs): >0.5 per 10(6) Peripheral blood mononuclear cell (PBMCs) in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10(6) PBMCs. ((6) is superscript).
= Seroconversion was defined as >4fold increase in endpoint titer between pre- and post-vaccine samples and a post-vaccine reciprocal titer >10.
= Response is defined as a >2fold increase over the baseline value of ASC per 10(6) PBMCs, when the number of ASCs is >0.5 per 10(6) PBMCs in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccine value was greater than 1.0 per 10(6) PBMCs.

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 2 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 5 μg of polysaccharide and 125 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum)
CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)

Two vaccinations (one on Day 0 and one on Day 28) with an intramuscular dose of Capsule-Conjugate Campylobacter Vaccine (CJCV1) equivalent to 10 μg of polysaccharide and 0 μg of Alhydrogel®, aluminum hydroxide adjuvant (Alum) CJCV1: The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)

Anti-CPS IgG ASC Responses - GMTs with 95% CI.
A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma).

Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells

Anti-CRM^197 IgG ASC Responses - GMTs with 95% CI.
A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma).

Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses

CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56

Interferon Titers Among All Cohorts

Overall Study

Ramiro Gutierrez, MD

Campylobacter Infection

The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)

Capsule-Conjugate Campylobacter Vaccine (CJCV1)

Alhydrogel®, aluminum hydroxide adjuvant (alum)

Walter Reed Army Institute of Research

Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea

Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)

U.S. Army Medical Research and Development Command

Walter Reed Army Institute of Research (WRAIR)

Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets

Irritable Bowel Syndrome

oral, sachet, 2 grams three times daily for 8 weeks

AST-120

oral, placebo, sachet, 2 grams three times daily for 8 weeks

Celphere® CP-305

Clinical Research Associates

Northern California Research

Medical Center for Clinical Research

Madeleine DuPree, MD

Michael Epstein, MD

Chevy Chase Clinical Research

Long Island Gastrointestinal Research Group

LeBauer Research Associates

Peters Medical Research, LLC

Ohio Gastroenterology and Liver Institute

Oklahoma Foundation for Digestive Disease

Breco Research LTD

Wisconsin Center for Advanced Research

AZ St. Lucas Assebroek

Zuid-Oost Limburg Campus St. Jan

UZ Leuven

UCL St. Luc

Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

aluminum/diarree

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea

Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

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